FDA Panel Recommends Novartis MS Drug

 |  Includes: BIIB, MRK, NVS, SNY, TEVA
by: The Burrill Report

By Michael Fitzhugh

A Food and Drug Administration panel has unanimously backed the safety and effectiveness of Novartis' (NYSE:NVS) multiple sclerosis treatment fingolimod. The panel voted 25-0 in support of fingolimod's “substantial evidence of effectiveness” in treating patients with relapsing remitting multiple sclerosis. That makes it likely the drug will be the first oral MS treatment to gain FDA approval, beating Merck (NYSE:MRK), Sanofi (NYSE:SNY) and Teva (NASDAQ:TEVA) - all of which are developing their own oral MS drugs - to the punch.

Leading interferon-based therapies for MS such as Biogen Idec's (NASDAQ:BIIB) Avonex and Bayer's Betaferon/Betaseron are both administered by injection, an unpleasantness likely to make oral medications appealing.

“If the FDA agrees that fingolimod is safe and effective, this would represent significant progress for people with MS–the first oral disease modifying therapy – and would help address the unmet need for additional therapies,” says Aaron Miller, chief medical advisor National MS Society. Analysts predict fingolimod could ultimately win an annual $1 billion or bigger slice of the $8.6 billion MS treatment market if it's approved, as expected, in September.

Novartis has said it plans to market the drug under the name "Gilenia," but the FDA has not yet accepted that plan.

While the panel concluded that the 0.5 milligram dose of Gilenia Novartis will market has an acceptable risk profile, the company will nonetheless be required to conduct a post-approval study of its side effects, which can include heart problems, seizure, tumors, infection and eye disorders, according to the FDA.

Notable blood pressure and pulse rate abnormalities upon some patients' first dose of the drug were also noted, leading the panel to recommend heart monitoring following initial treatment.

Merck revived its own effort to get an oral MS treatment through the FDA this week too, resubmitting an application seeking approval for cladribine, its therapy for relapsing forms of multiple sclerosis. The company, which is also seeking approval for cladribine in Europe, was held back from filing in November 2009, when the FDA refused to move ahead with its original new drug application.