May 14, 2012
Company news: two drugs clear FDA panel
Arena pharmaceuticals' weight loss drug Loquess (lorcaserin) is this year's second weight-loss drug to get the green light from an FDA advisory panel. The drug got an 18-4-1 endorsement during Thursday's vote. Vivus's drug Qnexa got a panel go-ahead in February. Thursday's decision is not binding, and the drug still has to win the overall agency's approval before consumers can add the remedy onto its list of slimming strategies. Yet the numbers belie the discussions surrounding the drug, particularly with respect to cardiovascular risk and pre-market approval. In a live-blogging session by The Street's Adam Feuerstein, panelists were concerned about how the drug could damage heart valves, though panelists said it was too late to demand Arena eliminate the possibility of heart risk at this point, because they weren't asked to. Panelist Sanjay Kaul said the drug did not provide clinically meaningful weight loss and that analysis “failed to rule out unacceptable risk,” for heart damage. Although Kaul voted against the drug, he also said it would have been unfair to ask Arena to eliminate the possibility of CV risk so far into their testing.
Gilead Sciences landed a 13-1 FDA panel vote for its HIV quad pill. The daily Truvada/elvitegravir integrase/cobicistat compound was tested for HIV patients who are on their first round of medical therapy. One nephrologist voted against the drug – kidney safety was a concern among panelists. Jefferies analyst Thomas Wei said in a research note that one panelist said the drug's once-a-day regimen and lack of CNS side effects made the combo appealing. It is expected to go up for a full FDA vote by August 27.