Posts Tagged ‘lorcaserin’

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


 

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.

Pharma Companies Hang in There

May 15th, 2011

Drug companies battered by the FDA earlier this year are not taking no for an answer. Vivus Inc. is in discussion regarding Qnexa to make it available for men and women who are not of childbearing age.  UPDATE 1-Vivus to submit Qnexa application as limited indication, shares up | Reuters  Arena Pharmaceuticals  is looking at a three month study of breast tumors in rats rather than the 12 month study the FDA wanted.   Arena pushing shorter study of rejected diet pill – SignOnSanDiego.com  while Orexigen is examining cardiac function effects of its drug, Contrave, see Orexigen submits diet-pill test plan to FDA – SignOnSanDiego.com

What’s Up with the FDA? – Part 2

May 15th, 2011

I’m sorry are we bothering you with all this obesity stuff?

As you know the FDA was quite busy this last 12 months or so with reviews of Meridia, Qnexa, lorcaserin and Contrave. Meridia is off the market now while the other three are holding on for dear life. It came as no shock to those closely watching the meetings of the Endocrinologic and Metabolic  Advisory Committee that the FDA really doesn’t much like dealing with obesity. Now, we know why. They are not curing hypertension or diabetes. That’s what the head of the FDA drug center, Janet Woodcock, right,  wanted to see. And that’s what she told Reuters in this interview. FDA official sees drug approvals rising | Reuters

So, think about this for a moment, the top FDA drug official casually tosses off the FDA’s own guidances for developers of obesity drugs regarding efficacy and says, well, she wishes they were other drugs entirely. Imagine if she said, well, we have turned down this drug for breast cancer because it didn’t  improve Alzheimer’s disease or  cure multiple sclerosis. Or if she said of a drug rejected  for HIV/AIDs, that she would like to have seen it cure Parkinson’s disease?  Would she stay in office the rest of the day? Would it not be a huge embarrassment to the FDA, the HHS, the medical community, the Administration? Why is it  ok for obesity? Is is any less intellectually vapid?  Is that why one of people who works for her, running the Endocrinologic and Metabolic Advisory Committee process this year, apologized, APOLOGIZED! to the panel for “putting them through this unpleasantness.” The “unpleasantness” Dr. Coleman was referring to was the Committee’s job, namely, reviewing new drug applications for obesity. Dr. Coleman, went on to add, “I guess you should be thankful you don’t have to do this everyday for your living.” (See http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM232443.pdf at page  304) Is this a cry for an intervention, a plea for a new job? Or a sign of an institution so biased against all this obesity that no obesity drug will ever be approved no way, no how? Can these people give obesity drugs a fair hearing? The FDA has rules on Conflicts of Interest. How about rules on Lack of Interest?

FDA Spikes Another Obesity Drug

February 1st, 2011

Orexigen Therapeutics Inc. indicated today that the Food and Drug Administration (FDA) has, in effect, decided not to approve the company’s obesity drug, Contrave ® in spite of a federal advisory panel vote of 13-7 in favor of approval in December of 2010. The FDA is requiring the company to complete a lengthy and expensive pre-approval of cardiovascular risks. Previously, the FDA had rejected two other new compounds: one developed by Vivus Inc. (Qnexa®) and the other, lorcaserin, by Arena Pharmaceutical Inc. (Lorquess ®) The FDA also pressured Abbott Laboratories to take orlistat (Meridia®) off the market.

According to Morgan Downey, editor and publisher of the Downey Obesity Report, “The FDA has decided that the most significant threat to public health will not be treated by any drug. In the current environment, tap water could not be approved. This is the first time in the FDA’s history that it has decided to abandon a major public health challenge. No doubt the FDA will continue to regularly approve drugs which cause weight gain and to half-heartedly police dangerous and unproven dietary supplements claiming to achieve weight loss. These actions have driven both large pharmaceutical companies and small biotech companies out of obesity research and development. At this time, only Vivus Inc.’s Qnexa has a hope of meeting FDA’s approval.” The FDA has asked Vivus Inc. to explore databases to rule out birth malformations due to one of its elements.

                                                            ###