Shortly after recommending approval of Qnexa (Phentermine / Topiramate), the FDA advisory panel this week also voted to approve Arena Pharmaceuticals weight loss drug, Lorgess (Lorcacerin). This medication has been in clinical trials over the past several years and works through the 5HT2c sub-type Seratonin receptor in the brain.
Why is this important? What is 5HT2c? Well, Lorgess is a seratonin agonist – that means it triggers the release of seratonin. Sound familiar? The big hit weight loss drug of the 90′s, Fenfluramine worked as a seratonin agonist as well. That was when it was discovered that we had seratonin receptors in lots of places, not just our brains. In fact, we have a seratonin receptor in heart valves. That’s why Fenfluramine caused heart valve damage.
Fast forward to 2012. We now have the technology to target specific seratonin receptors. By targeting the 5HT2c receptor, Arena Pharmaceuticals has been able to develop a medication that targets only the brain, with little to no activity in the heart. They have done careful safety studies, and have proven that their new obesity drug is both safe and effective.
The FDA panel is scheduled to vote on Qnexa on July 17th, and on Lorgess on June 27th, but they are under no obligations to follow their advisory panel’s advice.
So, will 2012 be the first year in 13 years that we get a new obesity treatment? Stay tuned…
Today the FDA announced that instead of reviewing Qnexa, the new weight loss drug by Vivus, combining Phentermine and Topiramate, they are pushing back the review date by 3 months to July 17th, 2012, to allow time to review all of the submitted data that Vivus provided the FDA.
“MOUNTAIN VIEW, Calif., April 9, 2012 (GLOBE NEWSWIRE) — The U.S. Food and Drug Administration (FDA) informed VIVUS (Nasdaq:VVUS) of an extended Prescription Drug User Fee Act (PDUFA) date for its review of the Qnexa New Drug Application (NDA) from April 17 to July 17, 2012. The three-month extension is a standard extension period.
On April 4, 2012, following the FDA’s request, VIVUS submitted the Qnexa Risk Evaluation and Mitigation Strategy (REMS), which was considered a major amendment to the NDA. The submission consisted of proposed REMS materials. Since the receipt date was within three months of the user fee goal date, the FDA is extending the PDUFA date by three months to provide time for a full review of the submission.
“The Qnexa REMS submission is comprehensive, with materials based on ongoing feedback from the FDA since our advisory committee meeting in February,” stated Leland F. Wilson, chief executive officer of VIVUS. “We look forward to finalizing our REMS with the FDA while we move forward with our commercialization plans.”
The Qnexa NDA seeks approval for the treatment of obesity, including weight loss and maintenance of weight loss for obese patients (BMI ≥ 30 kg/m2), or overweight patients (BMI ≥ 27 kg/m2) with weight-related co-morbidities such as hypertension, type 2 diabetes or dyslipidemia. Obesity is the second leading cause of preventable death and directly contributes to numerous life-threatening conditions including diabetes, cardiovascular disease, hypertension and stroke.”
