The WSJ reports that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended that oral MS drug, Gilenya, be approved for the treatment of patients with highly active relapsing-remitting multiple sclerosis.
The news should pave the way for EMA approval and give Novartis the chance to launch this purported blockbuster in 2011. The EMA final announcement is expected in about 3 months. An approval will give Novartis a further leg up on its competitor Merck KGaA's cladribine which failed to get market approval in Europe. Biogen Idec also failed (coincidentally) on Friday to gain EU approval for its oral MS drug, Fampyra. Novartis will soon be able to go after its share of the $10 B MS market.
Novartis will present a strong challenge to the others MS drug players including Biogen, Bayer and Teva. Teva's Copaxone had $2.8 B in sales in 2009 and Biogen's Avonex added accounted for another $2 B. Because Gilenya is a pill and not a daily injection, analysts believe Gilenya can vault to sales of $3.5 B or more. Patient groups welcomed the news. There are about a half-million MS patients in Europe.
Posted by Bruce Lehr Jan 23rd 2011.