As mentioned, "On an eventual Qnexa approval by the FDA, VVUS has some extra room to run."
Although the VVUS' drug was effective and showed a clear dose response that resulted in a median weight loss,at the high dose, of about 15% for patients who completed the 56 weeks of treatment,the FDA panel didn't recommend Qnexa for approval because of safety concerns.
That was in spite of the fact that Qnexa showed some good effects on other endpoints assoiated with obesity, including blood glucose, blood pressure, HDL and LDL cholesterol, sleep apnea., and inflammation markers.
It is possible that Qnexa may be approved in the future at a lower dose level,since the major problem is apparently the tachycardia associated with its phentermine component and not with the topirimate.
But that probably will require further trials.<g>
With GSK's Avandia having now questions about of whether it increases the risk of cardiovascular events, beyond those already related to the obesity itself, it seems that the FDA is going to be more strict or will be looking closer into the CV side effects of those drugs.
That's what seems to be helping ARNA, which was up 16.52% at 2:17pm and is still up 13.95% as I am writing this note.<g>
ARNA's Lorcaserin has slightly less than or equal efficacy to Orlistat and slightly less efficacy than Meridia.
And its safety profile appears to be better than that of Xenical (orlistat) or sibutramine and that could justify the approval for lorcaserin. The drug also appears to result in improvement of all surrogate measures of diabetes and cardiovascular risk.<g>
On Dec, after completing a PIII ARNA submitted an NDA for lorcaserin, which was based on data from 18 clinical trials totaling 8,576 patients.
And on Feb, the FDA accepted the NDA for filing and assigned a PDUFA, date of Oct22, for the review of their application.
At any rate, I would keep ARNA and leave VVUS out for the the time being pending further developments.
Bernard |
