Gilenia on track to become first oral MS drug

Novartis’ oral MS therapy Gilenia has been boosted by an FDA committee’s unanimous recommendation for its approval.

The drug is currently under an extended priority review set to end in September and the US regulator has the option of seeking the advice of one of its advisory committees during this period as it reviews and decides whether to approve a new treatment.

The committee voted unanimously that Gilenia (FTY720) demonstrated substantial efficacy in treating relapsing remitting MS and that safety of the proposed 0.5 mg dose justified approval.

Trevor Mundel, global head of development at Novartis, said: "Novartis is pleased by the committee's vote to recommend FDA approval of FTY720 as a treatment that has demonstrated substantial efficacy for relapsing remitting multiple sclerosis. The committee's positive vote affirms the favorable benefit/risk profile of FTY720 and we will work closely with the FDA as it finalises its review of our new drug application.

"If approved, FTY720 will offer patients an effective treatment in the convenience of a pill and we look forward to making this innovative therapy available for people with MS."

The committee evaluated clinical data that provided evidence of superior efficacy of Gilenia over one of the most commonly prescribed injectable treatments Avonex (interferon beta-1a), as well as placebo, in reducing relapses and brain lesions, a measure of disease activity.

In addition, the two-year placebo-controlled study showed Gilenia significantly delayed disability progression.

Dr Patricia O'Looney, VP of biomedical research at the National Multiple Sclerosis Society, said: "This is an encouraging and important milestone for the MS community.

"We believe that a treatment that reduces relapses and slows disability progression in a convenient oral formulation could encourage more people with MS to initiate treatment in the course of this life-long disease."

The FDA recommendation will be a boost to the Swiss pharma after rival Merck Serono re-submitted its oral MS therapy cladribine to the FDA this month after receiving a refuse to file letter in November of last year.

Both firms are in a race to have the first oral MS therapy to market and potentially snatch the mantle of standard MS treatment away from the intravenous form of interferon beta.

Novartis and Merck Serono both already market interferon beta treatments, Proleukin and Rebif respectively.

Ben Adams