Novartis' MS drug Gilenia cuts relapse rates, moving it forward in race with Merck KGaA's cladribine

Swiss drug major Novartis has presented positive new data for its multiple sclerosis drug Gilenia (fingolimod; FTY720) at the American Academy for Neurology (AAN) meeting taking place in Toronto, Canada, showing that the product reduced annual relapse rates by 62% for treatment-naive patients compared to placebo and by 44% for subjects who had received previous treatment, such as Avonex (interferon beta 1a).

Gilenia, which is under regulatory review in the USA and Europe, and has received priority status from the US Food and Drug Administration, is in a race to be the first oral MS treatment to reach the market, competing with German drugmaker Merck KGaA's cladribine which was filed in the USA last September, but the FDA rejected the filing two months later as incomplete, thus delayed the drug's approval (The Pharma Letter February 22).

Peak sales of $2-$2.5 billion forecast