By Michael Fitzhugh
Gilenya has become the first oral multiple sclerosis pill capable of slowing the disease's progression and reducing relapses to win approval from the U.S. Food and Drug Administration. Novartis (NVS), developer of the drug, beat Merck's (MRK) late-stage oral treatment cladribine to U.S. approval and could generate $1 billion in annual sales or more, according to both industry analysts and Novartis.
Many people suffering with MS in the United States are likely to take an interest in Gilenya as a potential alternative to injectable treatments from Biogen Idec (BIIB) and Bayer (BAYRY.PK), the current leaders in the $8.6 billion MS market.
“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,” says Nicholas LaRocca, vice president of healthcare delivery and policy research at the National Multiple Sclerosis Society.
Merck expects to hear from the FDA about cladribine approval before the end of the year, following the agency's decision to grant it priority review in July. Russia approved cladribine July 12 under the trade name Movectro.
Despite the FDA's endorsement of Gilenya, the agency says that patients using the drug should be monitored for a decrease in heart rate upon starting the drug and that it may also increase the risk of infections.
Biogen Idec, which sells two market-leading MS therapies, Avonex and Tysabri, used that suggestion as a jumping off point to remind patients that Gilenya’s long term safety profile “has yet to be established.” It also reminded investors about BG-12, its own late-stage MS drug.
Exactly how Gilenya works is unknown. Though it doesn't cure MS, it can slow the build-up of physical problems associated with the disease, possibly through helping people with MS keep certain white blood cells from attacking the protective coating around nerve fibers.
MS is a chronic, often disabling, central nervous system disease that can affect the brain, spinal cord, and optic nerves. About 400,000 people in the United States and 2.1 million people worldwide have MS, according to the National Multiple Sclerosis Society.