FDA Approves New Drug that Could Have Dramatic Impact on Your Life

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March 29, 2017

On Tuesday, March 28, the U.S. Food and Drug Administration approved a drug to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS).

The drug is called Ocrevus (ocrelizumab).

“This therapy not only provides another treatment option for this with relapsing MS, but for the first time provides an approved therapy for those with primary progressive MS,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.

“MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs more frequently in women than men,” the FDA said in a press release.

“PPMS is characterized by steadily worsening function from the onset of symptoms, often without early relapses or remissions,” it said.

In a study of 1,656 participants treated for 96 weeks, those who took Ocrevus had “reduced relapse rates and reduced worsening of disability” compared to a similar drug called Rebif.

Possible side effects of the drug include itchy skin, rash, hives, skin redness, low blood pressure, shortness of breath, swelling of the throat, nausea and a fast heartbeat.

The FDA also warned that the drug could increase the risk for malignancies, particularly breast cancer.

The most common side effect during the study was upper respiratory tract infections; and for PPMS, upper respiratory tract infection, skin infection and lower respiratory tract infection.

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