Qsymia phentermine/topiramate regulatory update

As expected, EMA's CHMP issued a negative opinion against approval of an MAA for obesity drug Qsiva phentermine/topiramate from Vivus. The committee expressed concerns over the potential cardiovascular and CNS effects associated with long-term use, Qsiva's teratogenic potential and its use by patients for whom the drug is not indicated. The committee noted that Vivus proposed measures to reduce the risk of off-label use, but CHMP considered the measures to be "difficult" to implement. Vivus plans to appeal the opinion and request a reexamination. Last month, Vivus said it expected CHMP to issue a negative opinion for the weight loss drug (see BioCentury, Sept. 24).

Separately, Vivus submitted to FDA an amendment to the existing REMS for Qsymia phentermine/topiramate that would allow select retail pharmacies to distribute the drug. The agency approved Qsymia in July with a REMS that requires the drug be distributed only through certified mail-order pharmacies (see BioCentury, Oct. 15). ...