An FDA advisory panel on Thursday voted 25-0 that Novartis' Gilenia (fingolimod) reduces relapses in patients with multiple sclerosis. The panel, which also voted 21-3 that the drug be approved as a first-line treatment, said that the drug appeared safe and effective for controlling tremors, concentration problems and other symptoms of MS.

 

The reviewers voted unanimously that the proposed dose of the drug "appears to have an acceptable safety profile." The panelists questioned whether a lower dose of the drug would be safer and voted 20-5 that Novartis should be required to conduct studies of the drug at lower doses after it reaches market. Robert Temple, director of the FDA's new drugs office, said the post-approval studies will include patients with diabetes and other conditions that might make them more susceptible to some of the side effects observed in previous trials of the compound.

 

An FDA staff report recently noted that while studies provided robust evidence of the efficacy of the drug, there were concerns about side effects.

The agency is scheduled to make an approval decision on the drug by September.