Arena Throws Their Hat In The Ring
This morning Arena Pharmaceuticals (NASDAQ:ARNA) announced that the FDA has accepted their new drug application for their weight loss drug Lorcaserin. According to a company issued press release; “Arena submitted the lorcaserin NDA on December 22, 2009, and expects to learn the Prescription Drug User Fee Act (PDUFA) date in the next few weeks.”
Arena now becomes the second company to submit a weight loss drug to the FDA, Vivus (NASDAQ:VVUS) was the first when they submitted their application for Qnexa to the FDA back on December 29, 2009.
Orexigen (NASDAQ:OREX) who’s weight loss drug, Contrave® has completed phase 3 trials and should be submitted to the FDA sometime later this year.
Given the current environment at the FDA it will be interesting to see who these applications move through the FDA. As Diabetic Investor has previously reported all three drugs appear to have decent data. Based on all available public data Qnexa and Contrave look to be ahead of Lorcaserin, however all three drugs did experience higher than normal dropout rates during their clinical trials.
It should also be noted that all three companies have positioned their respective drugs as part of the treatment options for patients with type 2 diabetes. Considering this fact and the renewed interest in drugs for type 2 patients, thanks to the Senate report on Avandia, Diabetic Investor suspects the FDA will take a long and hard look at all three drug candidates.
Handicapping what the FDA will or will not do is hard enough as it is, even under “normal” circumstances. Given the current set of circumstances Diabetic Investor wouldn’t dare to venture a guess as to what lies ahead for these drug candidates. As we have noted before we may not be the sharpest knife in the drawer but we’re not dumb either.
So like everyone else Diabetic Investor will take a wait and see attitude, looking for clues as the process moves forward.