US FDA delays approval for Novartis' oral MS drug candidate Gilenia (fingolimod)

Swiss drug major Novartis, which is vying with Germany's Merck KGaA to get the first oral multiple sclerosis drug approved by US regulators, suffered a setback, when the US Food and Drug Administration extended by three months, to September 2010, its review period for the regulatory approval of its MS candidate FTY720 (fingolimod), which has the proposed trade name Gilenia.

A meeting of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee remains scheduled for June 10, to discuss the benefit/risk profile of this new active ingredient, which has received priority review status from the agency. However, Novartis has previously explained that, because of the novelty of Gilenia, the FDA is likely to require an Advisory Committee meeting and evaluate the risk management program, which could result in the FDA extending its review.

Merck's oral MS candidate cladribine was submitted to the US regulator last September, but the FDA rejected the filing two months later as incomplete, thus delaying the drug's approval and apparently leaving Novartis in the lead (The Pharma Letter February 22).