EMA advisory committee backs Gilenya, Halaven, Jevtana, Pravafenix and Trobalt, but negatives for Fampyra and Multaq

The European Medicines Agency’s advisory body, the Committee the Committee for Medicinal Products for Human Use (CHMP), at its January meeting last week adopted positive opinions recommending the granting of marketing authorizations for the following new medicines:

• Swiss drug major Novartis’ (NOVN: VX) Gilenya (fingolimod), intended for the treatment of adult patients with relapsing remitting multiple sclerosis with high disease activity. The review for Gilenya began on 21 January 2010 with an active review time of 181 days.

"More than 500,000 people in the EU live with MS, a debilitating neurological condition that involves an unpredictable, life-long progression of complex symptoms," commented John Golding, President, European Multiple Sclerosis Platform (EMSP). "The first available oral MS treatment that offers significant efficacy for appropriate patients is a welcome alternative,” he added in a press statement from Novartis on the CMP decision.