FDA Approves Ocrevus to Treat Severe Form of Multiple Sclerosis
First drug sanctioned in United States for primary progressive multiple sclerosis
WEDNESDAY, March 29, 2017 (HealthDay News) -- The intravenous drug Ocrevus (ocrelizumab) has been approved by the U.S. Food and Drug Administration to treat adults with primary progressive multiple sclerosis (PPMS) and relapsing forms of the disease, the agency said Wednesday in a news release.
The FDA approval followed two clinical trials. One involved 732 patients with PPMS. Researchers found that those taking Ocrevus had less risk of their disability progressing compared with patients who were taking a placebo. In the other trial, which involved relapsing MS, those taking Ocrevus saw a reduction in their rate of relapses compared with patients taking Rebif (interferon beta-1a).
Upper respiratory infection was the most common side effect of Ocrevus among users with either PPMS or relapsing MS. Other potential side effects included skin infection and lower respiratory tract infection. The drug should not be used by patients with hepatitis B or known allergic-like reactions to the drug. Symptoms of the latter may include itchy skin, rash, hives, skin redness, flushing, low blood pressure, fever, fatigue, dizziness, headache, throat irritation, and shortness of breath.
"Multiple sclerosis can have a profound impact on a person's life," Billy Dunn, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "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."
Approval of Ocrevus was granted to Genentech.