WASHINGTON - Obesity treatment manufacturers may need to study the heart risks of their medicines before US regulators weigh approval, Food and Drug Administration staff said in a report Monday.
Three California companies are competing to bring the first weight-loss pill to market in 13 years: Vivus Inc., Orexigen Therapeutics Inc., and Arena Pharmaceuticals Inc.
The FDA is set to decide on Vivus’s drug Qnexa by April 17. Arena’s medication faces an advisory panel on May 10.
An advisory panel will hold a hearing on the drugs in Silver Spring, Md., starting Wednesday. The FDA does not have to follow the panel’s recommendations. The potential approvals come 15 years after the fen-phen appetite-suppression drug combination had to be pulled from pharmacies when it was linked to heart valve abnormalities.
Arena gained 25 percent to $3.01. Vivus dropped 1.36 percent to $21.02, while Orexigen fell less than 1 percent to $4.85.
Arena’s application for review of its diet drug was accepted Monday by European regulators, according to a statement from the company.
An analysis by Vivus of the risks for Qnexa was “somewhat reassuring,’’ though the significance of an increase in heart rate was “uncertain,’’ FDA staff said in a report Feb. 17.
Orexigen agreed in September with the FDA to conduct a two-year study of heart risks for the drug Contrave.