Novartis gains FDA approval for Gilenya, first oral MS drug cleared in USA; says SOM230 effective against Cushing's disease

In what is a positive news day for Swiss drug major Novartis (NOVN. VX), the company announced this morning that it has received US Food and Drug Administration approval for its oral multiple sclerosis (MS) treatment Gilenya (fingolimod) 0.5 mg daily, a first-line treatment for relapsing forms of MS - the most common forms of the disease.

The FDA approval makes Gilenya the first oral treatment indicated for relapsing forms of MS available in the USA, beating Germany’s Merck KGaA (FWB: MRK in the race to do so with its cladribine, and follows recent clearance for marketing in Russia, which had previously also OKed the Merck drug (The Pharma Letter September 13).

"Today is a significant and encouraging day for people with relapsing forms of MS in the US," said Nicholas LaRocca, vice president of Healthcare Delivery and Policy Research at the National Multiple Sclerosis Society, adding: "A new treatment option that offers significant efficacy in the convenience of a capsule is a welcome alternative to frequent injections for individuals living with this chronic disease."