Today, an FDA advisory panel voted 18-4 to recommend approval of lorcaserin, developed by Arena Pharma (ARNA). The panel concluded that its benefits "outweigh the potential risks when used long term" in overweight and obese people. One panel member abstained from voting.
There was some rather emotional testimony given today from people who partook in the later stage lorcaserin trials, pleading with the FDA advisory committee to recommend lorcaserin for approval, testifying that the drug helped them to lose a large amount of weight that they could not do without the drug ... rather moving stuff in my opinion.
Lorcaserin is one of three experimental weight-loss drugs whose developers have been trying for a second time to win approval, after the FDA shot them all down in 2010 or early 2011 because of serious potential side effects.
Shares of Arena Pharma were halted before the pre-market earlier today, and were to resume trading shortly. It looks like I had the call on this one right my article earlier today, where I remarked lorcaserin would receive an approval on a vote that would cut 70/30.
When Arena resumes trading, I expect to see a bid near $7 a share.
Vivus' (VVUS) pill Qnexa was recommended by an advisory committee vote of 20-2 in February of this year. The Prescription Drug User Fee Act (PDUFA) date for its review of the Qnexa New Drug Application (NDA) was extended from April 17 to July 17, 2012, to allow for additional information to be presented to the FDA from Vivus.
On April 4, 2012, following the FDA's request, VIVUS submitted the Qnexa Risk Evaluation and Mitigation Strategy (REMS), which was considered a major amendment to the NDA. The submission consisted of proposed REMS materials.
Vivus' stock price was trading up in today's after hours session 0.88% to $22.89 a share.
Orexigen Therapeutics (OREX) and its weight loss drug Contrave, received a vote for approval from an FDA advisory panel in early 2011, but the FDA rejected the advisory panels recommendation, citing the need for further studies relating to the affects on the heart.
Shares of Orexigen were up 13.4% to $3.80 a share in today's after hours trading session.
It is my opinion all three of these drugs will be approved this time around by the FDA regulatory body.
Disclaimer: This article is intended for informational and entertainment use only and should not be construed as professional investment advice, but rather my opinions as a writer only. Always do you own complete due diligence before buying and selling any stock.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
