Armed with a new game plan to guard against potential safety issues, Vivus has marched back to the FDA with its resubmission for the weight loss drug Qnexa. Last fall regulators dealt the whole weight-loss field a setback when it rejected Qnexa, citing concerns about potential birth defects and cardio issues. In the resubmission Vivus ($VVUS) will caution against use of the drug by any woman who is capable of having a child.
Vivus is also proposing a risk evaluation and mitigation study to help resolve regulators' worries, all part of a strategy that was hatched last month as company officials sat down with the FDA in September. The next step belongs to the FDA, which will set up a new advisory panel meeting in the first quarter of 2012, with a final decision slated for the second quarter of the year.
Vivus had been engaged in a closely watched race with Orexigen and Arena Pharmaceuticals to grab the first new approval of a weight loss drug in more than a decade. Each of the developers, however, ran into some thorny safety concerns among experts as well as regulators. Orexigen gave up on its program, only to vow to return with a two-year, $100 million study that could warrant an approval. And Arena has been insisting that it will soon have everything it needs to go back for an approval. Its investigators have been putting together a case the developer hopes will erase any concerns about a potential cancer link.
What's driving them? A huge market of obese Americans. Excluding overweight women in their childbearing years, an estimated 80 million adults could still benefit from the drug, according to Arena. The race is still on, in a manner of speaking, but there are still plenty of concerns about what lies ahead for these biotech companies.
- here's the press release
- check out the Bloomberg report