Posts Tagged ‘Arena Pharmaceuticals’

Aetna to Reimburse Obesity Drugs

November 28th, 2012

Aetna, the nation’s third largest health insurer, has announced that it will provide reimbursement coverage for Vivus Inc’s obesity treatment, Qsymia, and Arena Pharmaceutical’s Belviq, which will go on the market next year.

No details are available yet on the duration of coverage or any requirements to show weight loss. Nevertheless, this is a major breakthrough in the resistance of the insurance industry to cover drugs to treat obesity.

 

Look AHEAD Crashes

October 22nd, 2012

 

Behind Look Ahead

The National Institutes of Health (NIH) has announced that the Look AHEAD trial has been stopped in its 11th year, two years short of completion. The extensive trial, involving over 5,000 patients at 16 centers, was intended to find out if there was increased mortality from intentional weight loss and to see if intentional weight loss among obese patients with type 2 diabetes would result in fewer cardiovascular (CV) events. At the end of the trial, there was no difference between the study group, which received intensive behavioral counseling and the control group which received standard diabetes education and occasional support group meetings.  The NIH press release indicates that both arms had lower CV rates that reported for patients with diabetes in previous studies. NIHNEWS: Weight Loss Not Reduce CV events in Type 2 diabetes

While this is news is something of a shock, many folks saw it coming. Two years into the trial, which began in 2001, the monitoring board noticed that the event rate in the control arm was much lower than expected. The expected CVD event rate in the control arm was 3.125% per year; in fact it was 0.7%. A committee was formed and made changes to the original study protocol designed to capture more events. These changes went into effect in 2008. There appeared to be three reasons for the lower event rate. First, while cardiovascular disease (CVD) is still the major cause of death in the United States, mortality has gone down, resulting from better control of dyslipidemia and high blood pressure and improved care of chronic and acute coronary syndromes. (See NCHS Data Brief, NCHS DataBrief: Prevalence of Uncontrolled Risk Factors for CVD)  Second, study participants who choose to involve themselves in a long clinical trial may well be healthier than a community sample and more motivated to follow the diet and exercise and participation requirements. Finally, the Look AHEAD trial employed the Graded Exercise Test which excluded participants most likely to develop CVD. Because of the low event rate, an additional primary endpoint was added (hospitalized angina) and the trial was extended for 2 years. (See PubMed: Brancati_Midcourse Correction to clinical trial whe the event rate is underestimated: the Look Ahead Study) Readers may recall that the SCOUT trial of sibutramine also had to revise its protocol midway through the study for the same reason, resulting in a population which was older and sicker than typical clinical population. In both cases, revising the protocol did not favor the intervention.

The stopping of Look AHEAD raises a host of questions. Was the study protocol correct? Did it end up studying healthy obese diabetics? Do long-term studies produce more noise than insight? Are we really studying the aging process when we cannot control for changes in health status, drug utilization (including drugs which can increase weight) and changes in energy intake, fitness levels, etc.? What is the picture for sub-groups, such as the 60-74 age group which had good weight loss in the DPP and 4 year results of Look AHEAD? Were there specific improvements, such as reductions in medications usage, fewer hospitalizations or shorter length of stays, improvements in quality of life? Did the presence of any the alleles associated with success in bariatric surgery affect outcomes? PubMed: High allelic burden of four obesity SNPs associated with poorer wt loss.  Should future efforts be devoted to cases where the disease process is already well-established or where high-risk populations can be identified and appropriate interventions evaluated? In future trials, should comorbid management be left to the local standards of care or defined in the study protocol?

Looking Ahead of Look Ahead

Whither behavioral lifestyle interventions?

The lifestyle interventions in the DPP and Look AHEAD were regarded as the ‘gold standard.’ They involved recruiting and training health professionals who provided not only the intervention but provided a supportive environment and a community spirit. Extensive communication with the patient was maintained. PUBMED: Look AHEAD: Description of the Lifestyle Intervention. Look AHEAD  participants even received an honoraria of $100 at each annual visit to improve adherence. (FDA EMDAC Hearing, March 28, 2012, Dr. Rena Wing, transcript, p. 169).

Recently the CDC and the NIH were looking at ways to take the DPP/Look AHEAD model to a more replicable model. The CDC’s National DPP program awarded $6.75 million in grants to develop lifestyle interventions program among people at high risk. One involves using the YMCA to provide lifestyle counseling. http://www.ymca.net/diabetes-prevention/ Questions will certainly be asked if highly trained professionals with incentives for participants did not produce better results will a down-scale program do better?

Whither diabetes prevention?

Look AHEAD was designed following the Diabetes Prevention Program (DPP). The DPP established that both lifestyle changes and metformin could reduce the incidence of type 2 diabetes, through weight loss, although lifestyle was superior to metformin alone. Look AHEAD was taking this important finding one step further asking whether weight loss among type 2 diabetics would reduce the incidence of cardiovascular events.

Even though the DPP has been promoted as a model for preventing the development of type 2 diabetes through weight loss, there were problems.

Dr. William Knowler of the National Institute on Diabetes, Digestive, and Kidney Disease (NIDDK) told the FDA Advisory Committee earlier this year,that, after three years of the DPP,

“the rates (of development of type 2 diabetes) have tended to flatten out and become parallel among all three groups. The rate of new development of diabetes has actually slowed down in the placebo and metformin groups, compared to what it was in the first three years. And the lifestyle group has flattened out a little bit at the end, but the difference that was attained has been largely maintained over time.  Notice, though, that over 10 years, although there still are remarkable treatment effects, if you look at things in an absolute sense, we can’t say that we still know how to prevent diabetes because, still, close to half of the people who enrolled in the trial developed diabetes over a 10-year period. But at least it’s been substantially delayed in those who have had the interventions.” ( FDA Endocrinologic and Metabolic Drug Advisory Committee Hearing on assessing cardiovascular safety of obesity drugs, March 28, 2012, Transcript, p 131-2).


(Figure: Diabetes Prevention Program Outcomes Study, Lancet (2009) 374; 1677-1686)

Is ‘delaying’ diabetes onset as powerful as ‘preventing’ diabetes from occurring in the competitive race for health care dollars and public attention?

Furthermore, a study earlier this year indicate poor outcomes in drug treatment of adolescents with type 2 diabetes with barely half showing glycemic control with metformin. PubMed: Clinical Trial to Maintain Glycemic Control in Youth with Type 2 Diabetes

Will the Look AHEAD experience affect FDA approval of drugs and devices to treat obesity?

The FDA has viewed obesity as a cosmetic issue and only recently acknowledged it as a disease, worthy of attention as other cardiovascular risk factors. They (meaning the FDA Endocrinologic and Metabolic Drug Advisory Committee and FDA staff) have started, just barely, to view obesity as a cardiovascular disease risk factor, like hypertension. They have also opined, from time to time, that if folks only ate less and exercised more, they would not need drugs. So how does this decision play into these views? On one hand, they may be convinced that obesity is not so easy to treat as they thought by diet and exercise. On the other hand, they may think that there is less need for anti-obesity medications because other treatments, e.g. statins, lipid-lowering drugs, anti-hypertensives, are doing their job in reducing CV risk factors. So, this view may raise the bar for approval of new anti-obesity medications. On the other (the third?) hand, we may need a re-definition of obesity which tones down its “diabetes-metabolic syndrome-mortality” axis and raises its “disability-mobility-quality of life” axis. (Running out of hands here, I would not underestimate the potential for greater evidence of obesity’s role in the development of various cancers).

The recent trend in thinking at the FDA Endocrinologic and Metabolic Drug Advisory Committee (EMDAC) has been to view anti-obesity medications narrowly as cardiovascular disease treatments. The EMDAC met on March 28th and 29th,2012  and discussed how to assess the cardiovascular benefits and safety of anti-obesity medications. At the end of March 28, Dr. Rasmussen, who is the Industry Representative on the committee had the following exchange with Dr. Eric Coleman of the FDA.

Dr. Rasmussen: In your (Dr. Colman’s) presentation, you showed that there are different            populations pre-approval and in post-approval studies. ..Are we compromising the risk-            benefit evaluation if we impose more risk-based patients pre-approval?

Dr. Colman: I’m not sure I understood your question. Could you rephrase it?

Dr. Rasmussen: Maybe I’m preempting some of the discussion that we’ll be having                        tomorrow, whether we should require more high-risk CV patients pre-approval to rule out        a upper bound of the 95 percent confidence interval. But by doing so, we will likely be                including older patients with established cardiovascular risk disease. And I’m wondering          whether including more of those types of patients will compromise the benefits side of                doing the benefit-risk evaluation.

Dr. Coleman: Yes. And it might be that if the program had the resources to do this, that              that would just be one component of the program, and that there would be other be other,        smaller, shorter-term studies where they could study lower-risk individuals, younger                   individuals for shorter periods of time.

Dr. Rasmussen: But my concern was based on the fact that the SCOUT study didn’t really – I      mean, it looks like it wouldn’t be actually be able to be approved if it was submitted pre-            approval. ..(FDA EMDAC, March 28, 2012, transcript at p. 334-5)

On the second day of the hearing, Dr. Rasmussen returned to the topic.

Dr. Rasmussen: So I would just like to add a little bit of perspective on what “enrichment”          (Editor: “enrichment” is the term used here by the FDA referring to adding persons at high        risk of CVD to the pool of subjects in obesity drug trials) in this context will mean. I mean, I      did a little bit of “back-of-the-envelope” calculation, and maybe we’ll have that confirmed        after lunch. But, I mean, current programs, approximately 3,000 patient-years of                        exposure generate 15 MACE events or so. Even if we were to double that patient-year                  exposure with a population of a 3-percent annual event rate coming to additional 60                    events, we would still only be able to exclude a doubling of the hazard ratio. So, I mean,              what we’re talking about here is actually completely shifting the population that we’re                going to study in obesity programs to establish cardiovascular disease and not necessarily        the population that we know actually seek treatment in the real world. So, I think that’s              worth keeping in mind, that enrichment may sound appealing because it sounds like we will       add a fraction of sick patients, but in reality, this will be a complete shift of the population.        (FDA, EMDAC, March 29, 2012, at p. 169)

(Dr. Rasmussen’s calculations appear correction. The cardiovascular safety trial the FDA asked Orexigen Therapeutics to undertake surpassed its original goal of 7,000 patients in process of enrolling 9,000 patients to find 87 major CV events earlier than expected. Orexigen: Press Release Contrave CV study.)

A bit later, Dr. Rena Wing was asked about the influence of statins on the Look AHEAD trial. She responded:

Number one, that more and more people are being treated with statins. There’s better                blood sugar control. There’s better hypertension control. So you’re going to have to look          at what’s going to happen to the event rates in these studies. I was very surprised that your      event rates that you’re showing me in many of these trials looked so high compared to the        event rates we’re seeing in Look AHEAD. Now, some of that is because we did do GXTs.                (Editor: Graded Exercise Tests.) We did select healthier patients. But I also think that if you      are doing trials, in the United States especially, and with diabetics where there’s more and        more emphasis on increasing the use of lipids, increasing their blood pressure control, that      you’re going to be driving down your risk factors, and you’re going to have more and more      confounds with medication. (FDA, EMDAC, March 29, 2012 transcript, at p. 346)

At the Cleveland Clinic’s Obesity Summit earlier this month, I asked cardiologist Steve Nissen about the FDA’s pushing companies to undertake clinical trials to rule out a CVD risk. He responded that one of the challenges of cardiovascular outcome studies of obesity drugs is that in order to get enough cv events you have to study patients with existing heart disease or at very high risk of a cv event . This pushes the trial into populations which are considerably sicker than the population likely to take the obesity drug. He suggested that FDA should look at absolute risk rather than the relative risk of the drug. If one looks at the absolute risk, you can study any reasonable population likely to take the drug. This change in the statistical approach allows one to study more typical populations.

 

In any event, it will be sometime before we know how the newer anti-obesity medications, like Contrave if approved), Belviq™ and Qysemia™ will impact cardiovascular disease risk factors.

Bariatric Surgery: Last Man Standing?

A study out of the Cleveland Clinic published in the New England Journal of Medicine in April, 2012 followed over 90% of 150 patients for 12 months. The study, a face to face comparison of medical therapy versus surgery in patients with uncontrolled type 2 diabetes, showed a clear superiority for bariatric surgery.  The proportion of patients achieving a hemoglobin A1c level of 6% after 12 months by medical therapy alone was 12%; for those in the medical plus gastric bypass surgical group it was 42% and for the medical plus sleeve-gastrectomy group it was 37%. Weight loss was greater in the gastric bypass group (-24kg) and sleeve gastretcomy group (-25.1kg) than in the medical therapy group (-5.4kg). Use of drugs for glucose control, lipids and blood pressure control decreased in the surgical group but increased in the medical group. PubMed: Bariatric surgery versus intensive medical therapy in obese patients with diabetes

In regard to cardiovascular risk factors, a systematic review of the literature on bariatric surgery analyzed over 60 studies involving 19,543 patients. At baseline, the mean patient was 41.7 years old, female and had a BMI of 47.1. Baseline prevalence of comorbid conditions which increase risk of CVD was hypertension (44.4%), diabetes (24%) and hyperlipidemia (43.6%). After correcting for publication bias, 36% of subjects had improvements in hypertension, 26% for diabetes and 34% for hyperlipidemia. Calculating the changes for mean participants, the authors found that a woman, without baseline CVD, diabetes or smoking, who is taking anti-hypertensive drugs, will move from an 8.6% 10 year global risk for CVD to a 3.9% risk. A man, with no CVD or smoking but whose diabetes and need for anti-hypertensive drugs resolves after surgery, will move from a 10 year global risk of 18.4% to 4.7%. PubMed: Bariatric Surgery and Cardiovascular outcomes: a systematic review

So, where are we? The gold standard of lifestyle change is tarnished. The drug story is muddy at best. Bariatric surgery is clearly producing the superior results. However, access to surgery is, and will remain, a problem. The challenge for the leaders in the field is to find ways to have surgery reach more people and not be a procedure for the 1 percent. Even with greater access to surgery, the obesity-diabetes epidemic will continue to be a major health crisis. It’s time to be humble in the face of this disease and realize a lot more research is going to be needed…and soon.

 

NYT Coverage of FDA Lorcaserin Decision

June 28th, 2012

Here is the New York Time’s coverage of the FDA’s historic decision on lorcaserin by Andrew Pollack.

Prescription Drug to Aid Weight Loss Wins F.D.A. Backing

By 

The first new prescription diet pill in 13 years won approval from the Food and Drug Administration on Wednesday, providing a new option for the roughly one-third of American adults considered obese.

Now the question is whether people will use it. Despite a seemingly huge market, diet drugs have not sold well in the past, in part because people tend to use them for only a short time.

The new drug, developed by Arena Pharmaceuticals of San Diego, has been known as lorcaserin and will be sold under the name Belviq by Eisai Inc., the American branch of the Japanese pharmaceutical company.

Before Belviq’s approval, only one anti-obesity medicine had been approved for long-term use — Roche’s Xenical, which reached the market in 1999 and is rarely used because of modest weight loss and unpleasant effects on the digestive system.

The history of diet pills has been marked by many safety problems and product withdrawals, which has made the F.D.A. reluctant to approve new drugs. Belviq itself was turned down by the agency in 2010, but Arena came back with new data that assuaged the agency’s safety concerns.

Some patient advocates and doctors who treat obesity say there is a need for new medicines to help to plug a “treatment gap” between diet and exercise, which do not work for many people, and the more radical option of bariatric surgery. They say obesity itself is a serious disease that causes other health problems like diabetes and heart disease.

In announcing the approval of Belviq, the F.D.A. suggested that it ascribed to that point of view. “Obesity threatens the overall well being of patients and is a major public health concern,” Dr. Janet Woodcock, director of the drug evaluation center at the F.D.A., said in a statement.

Belviq is the first drug to reach the market for Arena, which was founded in 1997. Its stock price has more than quadrupled in the last two months, with much of the gain coming after an advisory committee to the F.D.A. recommended approval of Belviq by a vote of 18 to 4 on May 10. On Wednesday, the stock rose 29 percent to $11.39.

Arena said it was not clear yet when the drug would be available to patients and what it would cost. Because the F.D.A. deemed that there was some potential for the drug to be abused, the Drug Enforcement Administration must now decide what controls to place on prescribers, a process that Arena said could take four to six months.

Belviq provides only modest weight loss. In the two main clinical trials, those who took the drug lost an average of 5.8 percent of their weight after a year, while those using a placebo lost 2.5 percent. However, some 23 percent of the patients using Belviq lost at least 10 percent of their body weight.

Taken twice a day, Belviq activates a receptor in the brain, called serotonin 2C, in a way that controls eating and makes people feel full.

The main safety concern is that Belviq works somewhat like fenfluramine, a drug that was part of the popular fen-phen combination but was withdrawn from the market in 1997 because it damaged heart valves. The F.D.A. said Wednesday that it was satisfied that Belviq was unlikely to cause such problems.

The agency is not requiring patients taking Belviq to be monitored for valve damage. However, it recommends that people stop taking the drug if they do not lose 5 percent of their weight in 12 weeks, because they are not likely to benefit and should not be exposed to the risks. (About 40 percent of patients taking the drug in clinical trials achieved that much weight loss in 12 weeks.)

Arena committed to conducting six studies after the drug reached the market, including one to determine whether the drug increased the risk of heart attacks and strokes.

Some advocates hailed the approval. “The F.D.A. seemed so scared of another fen-phen recall that they had like a psychological hurdle to approve any new drug,” said Morgan Downey, editor of the online Downey Obesity Report. “I think they maybe now have gotten beyond that.”

The F.D.A. could approve a second obesity drug, Vivus’s Qnexa, next month.

But Public Citizen, the consumer group, called the approval a “reckless” action and predicted Belviq would eventually have to be taken off the market for safety reasons.

The next hurdle for Arena and Eisai will be selling the drug. This would seem easy given the tens of millions of obese and overweight people. Some analysts are projecting annual Belviq sales will exceed $1 billion.

But no other obesity drug has done that well. Only a small percentage of obese people use such drugs now.

While that is partly because there are few good choices, another issue is that insurers have been reluctant to pay for such drugs. Medicare Part D, which pays for drugs for seniors, explicitly excludes obesity drugs, along with drugs for erectile dysfunction and hair growth. Only 10 state Medicaid programs clearly pay for weight-loss drugs, according to a 2010 study by researchers from George Washington University.

Another issue is that patients tend to stop using the drug, in part because they are dissatisfied with the weight loss. The 5.8 percent average weight loss in the clinical trials of Belviq means that a person weighing 220 pounds, the average weight at the start of the trial, would still weigh 207 pounds a year later.

Even in the clinical trials, in which people tend to take drugs more faithfully than in real life, more than 40 percent of patients stopped taking Belviq before the year was out.

Dr. Ed J. Hendricks, an obesity specialist in Sacramento, said that he and other doctors might try prescribing Belviq in combination with phentermine, to essentially reconstitute the once popular fen-phen combination. “Once that word gets out that it works the same way, you are going to have a huge demand,” said Dr. Hendricks, who was on the advisory committee that voted in favor of approving Belviq.

Perhaps to discourage this, the label of Belviq states that the drug has not been tested for use with other weight-loss agents.

Christine Ferguson, a professor of public health at George Washington University, said one concern had long been that obesity drugs would be used by people who were not obese. “One of the challenges will be to ensure that it’s responsibly used,” she said.

 

 

FDA Approves Lorcaserin

June 27th, 2012

The Food and Drug Administration announced today that it has approvedlorcaserin (to be marketed as Belviq)for the treatment of adult obesity. The drug was developed by Arena Parmaceuticals and went through two advisory committee panels. The final panel voted to recommend approval by a vote of 18-4. This is the first drug for treating obesity approved by obesity since sibutramine was approved in 1997.

Lorcaserin is a novel drug that targets a specific serotonin receptor. It was a different serotonin receptor which was implicated in heart valve problems associated with use of the dexfenfluramine component of Fen-Phen. The FDA briefing document for the Advisory Committee meeting on May 10, 2012 states  that it “is unlikely at the proposed clinical dose” will activate the receptor implicated in the heart valve problem.

The receptor lorcaserin does impact is concentrated in the central nervous system (CNS) and regulates feeding behavior.

In the latest published study of the drug, the BLOOM-DM study led by Patrick O’Neil, 604 patients who were obese or overweight with type 2 diabetes were randomized into a treatment group and a placebo group. Both groups received lifestyle counseling. The group on drug lost 4.5-5% of their initial body weight while the placebo group lost 1.5%. PubMed: Clinical Trial of Lorcaserin in Type 2 diabetes Weight loss in patients with type 2 diabetes is notoriously difficult to achieve.  A 5% weight loss is considered to provide clinically meaningful changes. Weight reduction was evident at 2 weeks which means that patients who don’t see weight loss are likely to discontinue use early on in treatment. Glycemic control improved more in the lorcaserin group. There were not significant changes between the group on drug and on placebo in regard to cholesterol, triglycerides and blood pressure. The lack of statistical significance may be due to the use by a majority of patients being on blood pressure or lipid medications at the start of the trial.

Arena Pharmaceuticals, developer of lorcaserin, has agreed to conduct a number of post-approval trials, including one to assess cardiovascular effects.

 

FDA Panel Approves Arena’s lorcaserin

May 10th, 2012

After a long day of discussing the significance of tumor development in rats taking lorcaserin, the FDA Endocrinologic and Metabolic Advisory Committee reversed a negative vote 2 years ago and have recommended approval by a vote of 18-4. FDA does not have to follow their recommendation but the FDA reviewers are satisfied that the drug has low risks. I expect they will approve it in the near future.

 

Sign Up for Future FDA Hearings

April 17th, 2012

The safety and effectiveness of lorcaserin, developed by Arena Pharmaceuticals will be the subject of a meeting of the Endocrinologic and Metabolic Drug Advisory Committee on May 10, 2012. April 18, 2012 is the deadline for filing a request to present oral testimony. See http://www.fda.gov/AdvisoryCommittees/Calendar/ucm296516.htm

Medical Devices for the treatment of obesity will be the subject of two days of a meeting of the Gastroenterology and Urology Devices Panel on May 10 and 11, 2012.  The committee will discuss general issues regarding trial design for clinical studies on the safety and effectiveness of weight loss devices. The deadline for signing up for participating as a public witness is April

http://www.fda.gov/AdvisoryCommittees/Calendar/ucm297473.htm?utm_source=fdaSearch&utm_medium=website&utm_term=Gastroenterology%20advisory%20committee&utm_content=1


 

FDA Panel OKs Qnexa

February 23rd, 2012

Yesterday, the Endocrinologic and Metabolic Drugs Advisory Committee  voted overwhelmingly, 20-2, in favor of approval of Vivus Inc.’s anti-obesity drug, Qnexa. It was one heck of a surprise.

The morning session included presentations by the company and the FDA staff on the effectiveness of Qnexa and, especially, the safety profile. The safety issues involved the issue of whether additional birth defects, particularly oral clefts, would result from wider administration of topiramate and whether phentermine contained a risk for cardiovascular events. The panel members were clearly wrestling with understanding the data. The company presented a very comprehensive Risk Evaluation and Management System (REMS) plan to reduce exposure to the drug by women of child-bearing potential. During the discussion, committee members and the FDA expressed concern that the REMS program might be too restrictive. They observed that if access were too limited, patients could do what they are doing now – use the two drugs in the generic forms off-label for obesity treatment.

Considering the cardiovascular risks, they were concerned about the relatively weak,  but nevertheless present, sign of increased heart beats per minute and what that meant. This indicated a cardiovascular outcomes trial (like the SCOUT study for Meridia). The issue was whether the study would be done prior to approval or post approval. The key comments were made by Dr. Sanjay Kaul, usually a hawk on the obesity drugs, who opined that having the trial conducted post-approval would not be unreasonable. The effectiveness of the drug, about a 10% weight loss over a year, was the tipping point.

During the public witness part of the meeting, I testified, along with Ted Kyle for the Obesity Society, Denise Bruner for the American Society of Bariatric Physicians, Chris Gallagher for the American Society for Metabolic and Bariatric Surgery and Joe Naglowski for the Obesity Action Coalition. Ever since Qnexa was turned down in July 2010, we had been encouraging each other to testify and hold up the case for recognition of obesity as a disease and requiring additional tolls to fill the ‘treatment gap’ between lifestyle changes and bariatric surgery.

We huddled together as the votes were cast. The discussion among the panel members all day was of the ‘one the one hand on the other hand’ type. We expected a close vote.  So, we nearly fell over at the 20-2 vote in favor of approval. Of course, the FDA has the final word and it does not have to follow the recommendations of the panel. Nevertheless, it seems more likely than not that the FDA will approve.

At the end of day, I felt that the long shadow that the phen-fen debacle has cast over the FDA might be lifting and that the panel may have achieved a higher recognition of the enormous implications of our ever growing obesity epidemic.

Arena Pharmaceuticals and Orexigen Therapeutics  are still in the game with their drugs. While this positive vote, on the one hand may be good news for them, it may also set the effectiveness bar at a height their drugs cannot meet. Time will tell.

Arena to Get Second Shot at Approval

February 2nd, 2012

Arena Pharmaceuticals Inc. (and its partner Esai Inc.) have announced that they have been informed by the Food and Drug Administration that an Advisory Committee meeting will be held in the second quarter on their weight loss drug candidate, lorcaserin.  Arena Pharmaceuticals Receives Notice from FDA of Advisory Committee Meeting for Lorcaserin (NASDAQ:ARNA)  Arena is expected to produce information on efficacy and tumor development with their drug.