Food and Drug Administration Approves First Drug for Treating Severe Multiple Sclerosis
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Food and Drug Administration Approves First Drug for Treating Severe Multiple Sclerosis

Ocrevus treats adult patients with primary progressive multiple sclerosis

March 29, 2017

The Food and Drug Administration (FDA) has approved Ocrevus, the first drug for treating severe multiple sclerosis (MS).

Ocrevus treats adults with relapsing forms of MS as well as primary progressive multiple sclerosis (PPMS). It is injected into the patient's veins by a healthcare professional.

"Multiple sclerosis can have a profound impact on a person's life," said Billy Dunn, M.D., who directs the Division of Neurology Products at the FDA's Center for Drug Evaluation and Research. "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."

MS is an autoimmune nervous system disease that affects communication between the brain and other parts of the body. It is chronic and inflammatory, and it is one of the most common causes of neurological disability in young adults. Women experience MS more often than men.

For most patients, MS episodes of worsening function (relapses) are followed by periods of recovery (remissions) at the onset of the disease. Over time, they may not recover from these episodes completely each time, resulting in a progressive decline in function and more disability.

PPMS patients generally experience steadily worsening function from the beginning, frequently without early relapse or remission episodes. According to the U.S. Centers for Disease Control and Prevention (CDC), roughly 15 percent of MS patients have PPMS.

People experiencing a hepatitis B infection or who have a history of life-threatening reactions to the drug related to infusion should not use Ocrevus. Such reactions can include itchy skin, rash, hives, skin redness, flushing, low blood pressure, fever, tiredness, dizziness, headache, throat irritation, shortness of breath, swelling of the throat, nausea, and fast heartbeat. It may also raise the risk of malignancies, especially breast cancer.