Switzerland-based drugmaker Novartis AG said its investigational oral multiple sclerosis drug fingolimod (FTY720) has received unanimous approval from an FDA expert advisory committee, pending final approval from the regulator.
If approved, FTY720 would potentially be the first oral therapy for treating relapsing multiple sclerosis (MS), the company said.
The FDA will take this committee’s recommendation into account as it completes its review of the clinical trials’ benefit and safety data. The agency is expected to make a decision about whether to approve the drug by September 2010.
The advisory panel also recommended post-marketing collection of additional safety data and evaluation of a lower dose.
The committee's positive vote affirms the favorable benefit/risk profile of FTY720 and we will work closely with the FDA as it finalizes its review of our new drug application, said Trevor Mundel, MD, global head of development at Novartis Pharma AG.
The committee voted unanimously that FTY720 showed substantial efficacy in treating relapsing remitting MS and that safety of the proposed 0.5 mg dose justified approval, Novartis said.
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, National MS Society Chief Medical Advisor Aaron Miller said in a statement.
Robert Lisak, MD, Chair of Neurology and Professor of Immunology and Microbiology at Wayne State University School of Medicine in Detroit, agreed. I would welcome having another treatment option for my patients, particularly an oral medication that might make it easier for people to get on and stay on therapy.
MS, a chronic, unpredictable disease of the central nervous system, affects 400,000 people in the United States and over 2.5 million people worldwide.
Applications for regulatory approval for FTY720 were submitted to the FDA in December 2009. In February 2010, the FDA granted FTY720 priority review status. In May, the FDA extended the priority review period by three months to September 2010.
Major players in the MS market are Biogen Idec’s Avonex and Tysabri, Merck Serono’s Rebif, Bayer Schering’s Betaseron and Teva Pharmaceutical’s Copaxone.
Analysts expect FTY720, once launched, will compete primarily with Biogen, which is the current market leader in the treatment of MS.
American depositary receipts of Novartis ended up 3.3 percent at $47.45 in the New York Stock Exchange on Thursday.