Novartis gets Russian approval for oral MS drug Gilenya (fimgolimid)

Swiss drug major Novartis (NOVN. VX), which is in a race to bring oral multiple sclerosis drugs to the market with Germany’s Merck KGaA (FWB: MRK), has received approval from the Russian health authority, the Federal Service on Surveillance in Healthcare and Social Development, for Gilenya (fingolimod; also using the brand name Gilenia) 0.5mg once-daily oral therapy for the treatment of relapsing remitting MS.

Around 85% of patients with MS are estimated to have the relapsing remitting form at the onset of disease. Russia is the first country to approve Gilenya, providing a new treatment option offering significant efficacy for patients in the convenience of an oral capsule. Novartis expects to launch its product in Russia in early 2011. Merck gained Russian approval for its oral MS drug cladribine in July, and more recently also in Australia, where it will carry the name Movectro (The Pharma Letter September 6).

US approval decision expected by September 21