Novartis has received approval for its once-daily oral multiple sclerosis drug Gilenya from Russia, the first country to give the pill the thumbs-up.
The Federal Service on Surveillance in Healthcare and Social Development, the Russian health authority, has given the green light to Gilenya (fingolimod) for relapsing-remitting MS. Novartis expects to launch Gilenya, the first in a new class of compounds called sphingosine 1-phosphate receptor modulators, in Russia in early 2011.
The approval comes two months after Russia backed Merck KGaA's rival oral MS drug Movectro (cladribine). However, Novartis is ahead in the USA, after the Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee recommended approval of fingolimod, in June.
The FDA is expected to give its final decision this month and Gilenya is also under review by the European Medicines Agency.