The Wall Street Journal assesses the race among three biotechs to develop a blockbuster new obesity drug. Arena Pharmaceuticals and Vivus are on track to file for an approval by the end of this year, with Orexigen Therapeutics slated to follow soon after. And the Journal gives the lead to Vivus' Qnexa, which has hit two key endpoints laid down by the FDA for an approval.
Regulators in the U.S. have a clear set of benchmarks for an obesity approval. The FDA wants to see at least a third of trial participants lose at least five percent of their body weight, with the tally at least double that of the placebo arm. Or they ask for average weight loss that's five percentage points ahead of the control arm. Then there are special conditions. Arena's lorcaserin, for example, has sailed through trials with minimal side effects. And Orexigen, a developer manned at the top by a group of veterans from Amgen and big pharma companies, added an antidepressant to their drug that could make it more effective for a subset of patients.
The stakes are high. Analysts note to the Journal that one percent of the market is worth a blockbuster billion dollars. And that means that just getting an approval is a big deal, no matter whether the developer wins, places or shows in this race.
- check out the report from the Wall Street Journal