First drug sanctioned in U.S. for primary progressive MS
WEDNESDAY, March 29, 2017 (HealthDay News) -- The injected 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.
MS is an inflammatory autoimmune disease of the central nervous system, characterized by periods of active symptoms (relapses) and recovery periods (remission). Disrupting communication between the brain and the rest of the body, it's among the most common neurological causes of disability in young adults.
More women than men are diagnosed, typically between ages 20 and 40.
About 15 percent of people with MS have PPMS, the FDA said, citing the U.S. Centers for Disease Control and Prevention.
In clinical trials, 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 shouldn't be used by people 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.
Approval of Ocrevus was granted to Genentech Inc.
Visit the FDA to learn more.