Developing new obesity drugs is notoriously arduous--and it could get tougher. An FDA panel endorsed a plan to have developers of obesity drugs conduct cardiovascular safety studies even when data on the treatments give no indication that heart risks exist. If the FDA takes the panel's advice, developers of obesity drugs could face a longer road to approval.
The panel of experts voted 17-6 in favor of the additional cardiovascular studies, with some citing concerns about long-term use of weight drugs causing heart problems, The New York Times reported. There's still some gray area around whether the additional studies could hamper efforts to gain approvals. The committee seemed open to developers doing the cardio studies after approvals when no signs of heart dangers exist, and companies could capture cardio data in the course of their regular trials.
The vote comes as two developers of weight drugs, Vivus ($VVUS) and Arena Pharmaceuticals ($ARNA), have apps pending approval with the FDA. Vivus is up first with its drug Qnexa, which got the backing of FDA advisers for approval Feb. 22, and it's unclear whether the endorsement for additional heart safety studies will have an impact on the company's chances of gaining the agency's nod to begin sales. Data show the drug increases heart rate, and advisers had already floated the idea of the company doing cardio safety studies after potential approval of the treatment.
"… given what transpired at the Feb. 22 Qnexa panel and the overall tenor of this panel, we continue to believe that Qnexa will be approved by the April 17" FDA action date on Vivus's app for approval, analysts at Cowen & Company wrote in a note to investors this morning.
JP Morgan biotech analyst Cory Kasimov was also confident that Qnexa would get the FDA's approval stamp.
Still, there's been concern in the biotech community that raising the safety bar on drugs for obesity and diabetes has hurt investment in those fields and added cost and risk to developing new treatments for the conditions that affect many millions of Americans.
- check out The New York Times article
- and the report from Nature