CHMP backs Intelence, Vimpat, Rapinyl

EMEA's CHMP recommended approval of several drugs on Thursday, including Intelence etravirine ( TMC125) from Johnson & Johnson (NYSE:JNJ) to treat HIV-1 infection in antiretroviral treatment-experienced adults when used in combination with other antiretroviral agents. The non-nucleoside reverse transcriptase inhibitor (NNRTI) is already approved in the U.S.

The agency also issued a positive opinion on an MAA for Vimpat lacosamide from UCB (Euronext:UCB) for epilepsy. Vimpat selectively enhances sodium channel slow inactivation and modulates collapsin response mediator protein-2 (CRMP-2). It also is under review in the U.S. for the indication and in the EU and the U.S. for diabetic neuropathic pain. ...