The FDA approved Novartis' Gilenya (fingolimod) as a first-line treatment for relapsing forms of multiple sclerosis, the company announced Wednesday. The drugmaker noted that the approval "makes Gilenya the first oral treatment indicated for relapsing forms of MS available in the US."
Although clearance of the sphingosine 1-phosphate receptor modulator was widely expected after an FDA advisory panel recommended approval of the drug in June, Helvea analyst Karl-Heinz Koch said the restrictions placed on the treatment by the agency were less demanding than predicted. The drugmaker noted that a doctor will have to watch patients for six hours after their first dose of Gilenya.
"Gilenya has been approved for multiple sclerosis in the US with a prescribing label and a [risk evaluation] requirement that are probably the best possible outcome both Novartis and investors could have hoped for," noted JP Morgan analyst Alexander Hauber. "This is a very good outcome for Novartis. They’ll really be able to stir up the MS market,” Koch commented, adding that he now believes Gilenya can achieve double his earlier estimate of $1.4 billion in peak annual sales.
Approval of Gilenya was based on clinical data demonstrating that the drug showed significant efficacy in reducing relapses, the risk of disability progression, and the number of brain lesions in people with relapsing forms of MS, Novartis noted. The compound was previously approved in Russia, and regulatory filings are under review in other markets, including Europe.
Although some analysts suggest that an oral treatment could significantly alter the $8.6 billion annual MS drug market, JP Morgan analyst, Geoff Meacham, recently said a survey of doctors suggested Gilenya would have minimal impact on front-line MS drugs such as Biogen Idec's Avonex (interferon beta-1a), Merck's KGaA's Rebif (interferon beta-1a), Bayer's Betaseron (interferon beta-1b), and Teva's Copaxone (glatiramer), although it could have a larger effect on Biogen Idec's Tysabri (natalizumab).
Merck KGaA's oral MS drug, cladribine, has been approved in Russia and Australia, while regulatory decisions in the US and Europe are expected later this year. Other oral drugs in development to treat the disease include sanofi-aventis' teriflunomide, Teva's laquinimod, and Biogen Idec's BG-12.
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