Qnexa’s Second At-Bat

February 17th, 2012 No comments »

Interest is rising as Vivus Inc.’s next date with the Food and Drug Administration draws near. The Endorinologic and Metabolic Drug Advisory Committee meeting on February 22, 2012 will reconsider whether to approve Qnexa, which is a combination of phentermine and topiramate. Both drugs are already approved by the FDA and are available as generics.  The FDA has put out their briefing materials, as well as that from Vivus on their website. Endocrinologic and Metabolic Drugs Advisory Committee > Briefing Information for the February 22, 2012 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee

The materials indicate that the Advisory Committee will be debating how to mitigate the exposure by women of childbearing potential to half of the Qnexa compound, topiramate.

Media interest is reflected in a front page story by Andrew Pollack in the New York Times. Diet Treatment, Already in Use, to Get F.D.A. Review – NYTimes.com

FDA Sets Hearing on Cardiovascular Aspects of Obesity Drugs

February 9th, 2012 No comments »

The Food and Drug Administration (FDA) has announced two days of hearings on the role of cardiovascular assessment in the preapproval and postapproval settings for drugs and biologics developed for the treatment of obesity, March 28 and 29th, 2012 Advisory Committee Calendar > March 28-29, 2012: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement

Orexigen and FDA Agree on New Study

February 6th, 2012 No comments »

Orexigen Therapeutics Inc. has announced that it has reached agreement with the Food and Drug Administration on a new protocol to test for adverse cardiac events for it obesity-fighting compound, Contrave. Orexigen Therapeutics, Inc. – Press Release

NIH Recommends A1c Testing

January 26th, 2012 No comments »

The National Institutes of Health has come out for expanded A1c testing. Their press release and fact sheet point out that the A1c test does not require fasting and helps identify diabetes and pre-diabetes. They recommend testing of anyone 45 years old or younger than 45 are overweight, inactive or have at least one risk factor for type 2 diabetes. New NIH fact sheet explains test for diabetes, prediabetes, January 26, 2012 News Release – National Institutes of Health (NIH)

Allergan Slapped on Marketing Lap-Band

December 27th, 2011 No comments »

After the FDA slapped Allergan for the marketing campaign of one of its vendors,  2011 > 1 800 Get Thin LLC 12/12/11, the Los Angeles Times took on Allergan to do step up to the real work of corporate responsibility. Lap-Band maker needs to step up – Los Angeles Times. A lot of health care professionals who have worked with the company would not disagree with this position.

Below the Radar

December 23rd, 2011 No comments »

Before leaving for his holiday in Hawaii, President Barack Obama signed the appropriations bill to keep the government running. Included in the bill is a provision establishing the National Center for Advancing Translational Sciences (NCATS). This center is the brainchild of NIH Director Francis Collins. Statement by NIH Director Dr. Francis Collins – NIH Launches National Center for Advancing Translational Sciences, December 23, 2011 – The NIH Director – National Institutes of Health (NIH) It is intended to develop resources at NIH to facilitate moving basic biomedical research into treatments and removing roadblocks to incorporating new findings into patient care. Off the record, NIH officials are concerned that one of the bigger roadblocks is the failure of new drugs to gain approval by the Food and Drug Administration. Obviously, this includes drugs to treat obesity. While addressing this specific issue is not part of the NCATS mission, it clearly provides a platform to move in this direction. The very first activity of this center is a collaboration with FDA and DARPA to develop a chip to screen new drugs for toxicity. NIH, DARPA and FDA collaborate to develop cutting-edge technologies to predict drug safety, September 16, 2011 News Release – National Institutes of Health (NIH)

As it happens, my paper on the FDA approval process, written with colleagues,] Christopher Still and Arya Sharma, specifically called for a NIH-FDA-industry-patient group collaboration to find ways to overcome obstacles to the approval of drugs to treat obesity. What’s Up with the FDA – Part 5 | The Downey Obesity Report

So, keep an eye on NCATS. It may become very important and relevant to advancing the treatment of obesity. Proposed NCATS « Feedback NIH

Vivus Inc. Announces Date for FDA AdCom; results of birth defect study

December 23rd, 2011 No comments »

Vivus Inc. has announced that the FDA will hold an   Advisory Committee meeting on February 22, 2012 for review of the obesity treatment, Qnexa. VIVUS, Inc. – VIVUS Announces Date of FDA Advisory Committee Review of Qnexa for the Treatment of ObesityTwo days ago, Vivus Inc. released resulted of the FORTRESS study.  The study looked retrospectively at women delivered infants while taking topiramate, one of the two active drugs in Qnexa. Compared to women who had taken topiramate earlier but not during their current pregnancy, those taking topiramate during pregnancy reported a higher rate of cleft palates in their children (0.29% v. 0.16%) VIVUS, Inc. – VIVUS Reports Topline Findings From FORTRESS An earlier study unrelated to topiramate reported a higher rate of birth defects overall and cleft palate, in particular, in women with obesity compared to women of normal weight.

The company’s current application would limit distribution to men and women beyond child-bearing age.

Child Food Marketing Guidelines Set Back…Again

December 16th, 2011 No comments »

Food and beverage industry has won another victory in Congress (did you forget pizza?) , forcing through a provision which would require the three federal agencies involved in writing the new guidelines for marketing to children to undertake a cost benefit analysis. Lawmakers want cost-benefit analysis on child food marketing restrictions – The Washington Post Earlier in the year, the industry had forced the Administration to drastically curtail the age group covered by the proposed guidelines Food giants fight proposed nutrition guidelines – SFGate