Vivus Gets Obesity Drug Review Date
Obesity drug watchers, mark your calendars. In recent weeks, companies with experimental weight loss drugs in late-stage clinical trials have announced some important dates in the Food and Drug Administration’s evaluation process.
Save the dates:
July 15- Vivus Inc. has announced that an advisory committee at FDA is tentatively set to review the firm’s new-drug application for obesity drug candidate, Qnexa, at a meeting on this date.
October 22- Arena Pharmaceuticals has announced that this is the Prescription Drug User Fee Act (PDUFA) date for the firm’s experimental lorcaserin obesity medication. The PDUFA date is the goal date for FDA to finish reviewing the company’s new-drug application. This is when folks will be watching for approval decisions.
October 28- This is the PDUFA date for Qnexa.
A third company, Orexigen Therapeutics, has its Contrave obesity drug candidate in late-stage clinical trials, but has yet to file a new-drug application with FDA. The three companies are the furthest along in the race to bring new obesity drugs to market.
As we reported nearly a year ago, chemically speaking, only lorcaserin is actually new. The compound is more selective version of fenfluramine, better known as the “Fen” portion of the infamous blockbuster weight-loss drug combo Fen-Phen, which was pulled from the market. Lorcaserin is designed to avoid one of the serotonin receptors fenfluramine targeted- an activity that Arena believes was responsible for the heart valve defects Fen-Phen users experienced.
Qnexa contains drugs that are already FDA approved: it’s a low-dose combination of topiramate, an antiseizure medication that enhances feelings of fullness, and phentermine, the “Phen” part of Fen-Phen, which was not linked to heart valve defects.
The Fen-Phen craze teaches us that there could be millions of prescriptions for an FDA-approved weight-loss drug. Not all of them will be written for patients who are obese. Expect FDA to weigh drugs’ efficacy and safety very carefully.