FDA Advisory Committee unanimously backs Gilenia, putting Novartis ahead in race for oral MS drug

Despite some reservations about the safety profile of Swiss drug major Novartis' drug by US Food and Drug Administration reviewers ahead of an advisory panel meeting (The Pharma Letter June 9), the latter yesterday voted unanimously (25 to 0) to recommended approval of Gilenia (FTY720; fingolimod) for the treatment of patients with relapsing multiple sclerosis, the most common form of the disease.

Novartis is in a race to be first to market with an oral treatment for MS with Germany's Merck KGaA, which just this week resubmitted its filing for cladribine, after an earlier FDA refuse to file notification (TPL June 8). Current treatments in the global $7 billion MS drug market are injectables. The news saw Novartis' American depositary receipts rise 3.3% to $47.45 by close of trading last night, and advance 3.5% to 55.75 Swiss francs in trading this morning, with analysts projecting that Gilenia, if finally approved, could generate $1 billion or more in sales annually. The FDA is scheduled to make a final decision in September.

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