First drug for aggressive MS gets FDA nod

Drug manufacturer Genentech has gotten approval from the U.S. Food and Drug Administration for the nation’s first drug designed to treat Primary Progressive Multiple Sclerosis (PPMS), the disease’s most aggressive form. The drug, Ocrevus (orcrelizumab), has also been approved for standard forms of MS.

Ocrevus is only available as an intravenous infusion and must be administered every six months by a healthcare professional. In two separate clinical trials, the immune-suppressant drug extended remission phases and slowed disability development in MS patients and slowed degradation in PPMS patients.

“Multiple sclerosis can have a profound impact on a person’s life,” said Billy Dunn, MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research in an FDA announcement. “This therapy not only provides another treatment option for those with relapsing MS, but for the first time provides an approved therapy for those with primary progressive MS.”

The treatment period is a long one—the MS trail was 96 weeks, and the PPMS trial was 120 weeks. The drug’s main attraction is its relative lack of serious side effects compared to other treatment options, although it can interfere with live or attenuated-live vaccines, antibiotics and the treatment of other autoimmune diseases and infections, the FDA says.

Genentech has said it will charge a list price of $65,000 a year for the drug, less than EMD Serono’s competing drug Rebif, which lists for $86,000 a year. There are more than a dozen other MS drugs on the U.S. market, but few have the response rates of the newer classes.

Multiple sclerosis affects 400,000 people in the United States, and often ends in disability that requires skilled nursing care or significant home care. About 15 percent of MS patients have the aggressive form, PPMS.

Topics: Clinical