Novartis Wins EU Regulatory Approval for Gilenya MS Pill

Novartis AG won European approval to sell its multiple sclerosis medicine Gilenya for patients with active or severe forms of the disease.

The European Commission cleared the treatment for use against the relapsing-remitting form of multiple sclerosis, Basel, Switzerland-based Novartis said in a statement today. Doctors can prescribe the drug as the second choice of treatment for patients with an active form of the disease who’ve used beta interferon, or as the first drug for those with a rapidly evolving form of the disease.

The decision excludes some patients, giving the drug a smaller part of the European market than it has in the U.S. Gilenya won U.S. approval as the first choice for use in all patients with relapsing-remitting MS last year, raising hopes for some of the millions of patients who suffer from the disease and rely on injections for symptom relief. The Novartis tablet may earn as much as $2.9 billion a year worldwide through 2017, Joshua Schimmer, a Leerink Swann analyst, wrote in a note dated Feb. 4.

“Gilenya is the first approved therapy for MS that offers significant efficacy in a capsule, which for many patients will come as a welcome additional option,” Hans Peter Hartung, head of the department of neurology at Heinrich-Heine University in Duesseldorf, Germany, said in the statement.

The pill costs about $48,000 annually in the U.S.

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended Jan. 21 that Novartis be granted approval to market the drug.

Merck KGaA’s Rebif and Biogen Idec Inc.’s Avonex are both beta interferons, as is Novartis’s own Extavia.

MS affects about 2.5 million people worldwide, many of whom have trouble sticking with current therapies because they’re difficult to use or have side effects, according to the National Multiple Sclerosis Society, a New York-based patient group.

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