Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Novartis investigational treatment FTY720 (fingolimod) has received unanimous FDA approval for the treatment of patients with relapsing multiple sclerosis (MS).
Subscribe to our email newsletter
The advisory committee of FDA, that reviews and decides whether to approve a new treatment, has voted that FTY720 demonstrated substantial efficacy in treating relapsing remitting MS and that safety of the proposed 0.5mg dose justified approval.
Novartis said that the committee has assessed data from the clinical trial program which provided evidence of superior efficacy of FTY720 over ointerferon beta-1a IM (Avonex), and to placebo, in reducing relapses and brain lesions (a measure of disease activity).
Reportedly, the two-year placebo-controlled study showed FTY720 delayed disability progression. The advisory committee discussed monitoring parameters for the therapeutic use of FTY720 and also recommended post-marketing collection of additional safety data and evaluation of a lower dose.
Novartis stated that the FDA granted FTY720 priority review status in February 2010, reducing the standard 10-month review to six months. In May, the FDA extended the priority review period by three months to September 2010.
Novartis claimed that if approved, FTY720 would be the first oral therapy for treating relapsing MS. FTY720 would be the first in a new class of therapies developed for relapsing MS called sphingosine1-phosphate receptor (S1PR) modulators.
Patricia O’Looney, vice president of biomedical research at the National Multiple Sclerosis Society, said: “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 disease.”
Trevor Mundel, global head of development at Novartis, said: “Novartis is pleased by the committee’s vote to recommend FDA approval of FTY720.
“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 is expected to offer patients treatment in the convenience of a pill and we look forward to making this therapy available for people with MS.”