Losing The Battle Of The Bulge: FDA Holds Up Orexigen's Contrave
This article was originally published in Pharmaceutical Approvals Monthly
Orexigen Therapeutics has a big decision on its hands – how to proceed with its Contrave program – now that FDA wants to see a large cardiovascular outcomes study before the drug can be considered for approval.
You may also be interested in...
Where FDA Is Paying The Most Attention: Drug Safety Advisory Committee Had The Most Meetings In 2010
FDA’s ongoing efforts to ramp up its focus on drug safety are being borne out at the advisory committee level, which saw a doubling in the number of meeting days for the Drug Safety and Risk Management Advisory Committee in 2010.
FDA signaled during an advisory committee on Orexigen's weight-loss drug Contrave that it could be ready to revise its obesity drug draft guidance, particularly with regard to cardiovascular goals, but stressed that for now, the drugs under review are to be judged by standards articulated in the draft document.
FDA's Endocrinologic and Metabolic Drugs Advisory Committee's surprise vote recommending Orexigen Therapeutics’ obesity drug Contrave (naltrexone SR/bupropion SR) for approval has boosted hopes that at least some of the current generation of obesity drugs in development may reach the market – just not in the order that everyone had expected.