Orexigen ($OREX) put its best foot forward this morning, attempting to persuade a tough crowd of FDA advisors that its obesity drug Contrave warrants a timely approval.
"The road has been long and hard both for individual drugs as well as for the class," said Dawn Viveash, Orexigen's regulatory affairs chief. Tweeting on the discussion taking place today, TheStreet's Adam Feuerstein--who's been closely following the trio of obesity drugs now up for approval--noted that Orexigen did "as well as can be expected" in making its case, then added that there were "lots of questions about CV risk."
Analysts have zeroed in on the agency's concerns about blood pressure and other cardiovascular concerns which threaten to delay an approval until after a safety study is conducted--one of the questions the panel will vote on later today. The same panel has already turned thumbs down on experimental obesity therapies from Arena Pharmaceuticals and Vivus. And a host of safety issues have battered the drug category, reducing what could easily be a mega-blockbuster market to a mere $382 million in annual sales. Analysts have estimated that at its peak, Contrave alone could earn $1.2 billion a year.
The FDA staff is now reviewing the drug's efficacy and safety record during clinical trials. The vote on Contrave should be taken before 5 p.m. EST.
- here's the story from Reuters