Pop the cork and start the music, because it's time to celebrate. The FDA just approved its 22nd drug of 2011, surpassing its number for all 2010. And it's only August!
Who is our lucky record breaker? Gilead Sciences (Nasdaq: GILD) and its HIV combo drug Complera. It's similar to Gilead's Atripla, but thanks to a better deal combining Truvada with Johnson & Johnson's (NYSE: JNJ) Edurant rather than Bristol-Myers Squibb's (NYSE: BMY) Sustiva, Complera is potentially much more lucrative. The FDA decision lacked drama, since both Truvada and Edurant are already on the market, but smooth approvals are always a welcomed sight.
It was only a few months ago when the FDA found itself under attack from Republicans in Congress for being too slow in making with the approvals. While their seemingly endless passion against government regulation has its merits, the FDA has to balance risk versus reward. Get too loose with the process, and a Vioxx harms both citizens and the agency's reputation. The FDA responded that it has met in excess of 90% of its deadlines and that first-cycle approvals are higher than they have been since 1991.
Certainly, the FDA hasn't been easy on "lifestyle" drugs that help with problems like obesity. After asking Abbott Labs to pull Meridia, the FDA has been reluctant to approve similar products such as Arena's (Nasdaq: ARNA) locaserin, Orexigen's (Nasdaq: OREX) Contrave, and VIVUS's (Nasdaq: VVUS) Qnexa. All three received complete response letters and will have to address a host of issues before they hope to get approval. Showing additional health benefits would certainly help their ultimate chances of getting a green light.
On the other side of that coin is Mannkind (Nasdaq: MNKD), which had been battling over changing inhalers from MedTone to Dreamboat for its drug Afrezza. Shares are up more than 25% after the FDA gave approval for the design of two more trials, letting Mannkind move forward again -- although don't expect any results before 2013.
So what do you think? After investors jumped for Yervoy, Victrelis declared victory, shortly followed by Incivek, and the first lupus treatment in 50 years got the nod, are we officially dealing with a nicer and cuddlier FDA focused on getting drugs to market? Or are 2011's results simply reflecting a better crop of submissions? Let us know in the poll below.
