FDA Approves Ocrevus for the Treatment of Multiple Sclerosis

The US Food and Drug Administration (FDA) has approved Ocrevus (ocrelizumab), an intravenous infusion, for the treatment of relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS) in adult patients.

The effectiveness of Ocrevus for treating relapsing MS was determined in 2 clinical trials that included a total of 1656 participants treated with Ocrevus or Rebif (interferon beta-1a) for 96 weeks. Both studies showed that patients taking Ocrevus had reduced relapse rates and reduced worsening of disability compared with patients taking Rebif.
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In addition, in a study of 732 participants with PPMS treated for at least 120 weeks, those receiving Ocrevus showed a longer time to worsening of disability compared with placebo.

Infusion-relation reactions can occur with the use of Ocrevus, and include, but are not limited to, 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.

The most common adverse effect shown in patients with relapsing forms of MS receiving Ocrevus was upper respiratory tract infection. The most common adverse effects shown in patients with PPMS receiving Ocrevus were upper respiratory tract infection, skin infection, and lower respiratory tract infection.

—Melissa Weiss

Reference:

FDA approves new drug to treat multiple sclerosis [press release]. FDA. March 29, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm549325.htm?