The FDA has approved Gilenya for use in slowing the progression of multiple sclerosis and reducing the frequency of disease relapses. The drug, developed by Novartis, becomes the first federally approved oral treatment for the debilitating disease, which affects 400,000 people in the US and more than 2 million people around the world.
Novartis had been in a race with Merck to be first-to-market with an effective oral treatment for multiple sclerosis, a disease that attacks the central nervous system and causes symptoms ranging from double vision to gait abnormalities and even stroke-like symptoms.
Marck’s anti-MS drug, cladribine, will be reviewed and possibly approved by the FDA before the end of this year.
Industry analysts and Novartis expect Gilenya to achieve at least $1 billion in annual sales.
Until the FDA green-lighted Gilenya, the only FDA-approved options for MS patients were intravenous drugs produced by Biogen Idec and Bayer. Biogen’s products, Avonex and Tysabri are leaders in MS market, which is estimated to be worth $8.6 billion per year.
“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,” Nicholas LaRocca, a VP at the National Multiple Sclerosis Society told BurrillReport.
In approving Gilenya, the FDA warned that patients who take the drug should be observed for slow heart rates shortly after therapy begins, and that the drug may be associated with infections.
For its part, Biogen Idec added in a statement that the long-term safety of Gilenya “has yet to be established.”
The mechanism of action of Gilenya remains unknown. Many scientists believe it modulates a pathologic tendency for the body’s white blood cells to attack myelin, a fat-like substance that forms a protective sheath around nerve cells.