Friday, June 11, 2010

FDA panel votes to recommend approval for Gilenia

 

The Peripheral and Central Nervous System Drugs Advisory Committee, appointed by the FDA to conduct an expert review of Novartis' new oral MS drug Gilenia (aka fingolimod or FTY720), met today and voted to recommend approval for this therapy. The panel discussed the side effects that have been observed in clinical studies (such as cardiac problems, an eye disorder called macular edema, and impaired lung function), but ultimately decided that the benefits of Gilenia outweigh these risks. The panel did recommend that a lower dosage of the drug be evaluated -- but agreed that this additional study could take place after approval of the current proposed dose (0.5 mg). The committee also voted in favor of making Gilenia available as a first-line treatment rather than only as a back-up if other treatments don't work.
The FDA is expected to decide whether to approve Gilenia in September. It usually follows the advice of its advisory committees, although it's not required to. Assuming Gilenia is approved, it will most likely be prescribed in conjunction with a safety monitoring plan to identify any possible new issues with the drug.
All of the background materials that the committee considered for today's meeting can be downloaded openly from the FDA website. These include information submitted by Novartis and reports prepared by FDA's scientific and medical experts. If you're considering trying Gilenia if and when it becomes available, you may want to read through this information, especially if you are concerned about particular side effects.

Bookmark and Share