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FDA Approves New Drug for Multiple Sclerosis

Genentech news release; 2017 Mar 28

Genentech, a member of the Roche Group, has announced that the US Food and Drug Administration (FDA) has approved Ocrevus (ocrelizumab) as the first and only medicine for both relapsing and primary progressive forms of multiple sclerosis (MS). Genentech is headquartered in San Francisco, CA.

Indications: Ocrevus is a prescription medicine used to treat adults with relapsing or primary progressive forms of MS. It is not known if Ocrevus is safe or effective in children.

Dosage/administration: Ocrevus is administered by intravenous infusion every 6 months. The first dose is given as 2 300 mg infusions administered 2 weeks apart. Subsequent doses are given as single 600 mg infusions.

Adverse reactions: The most common side effects include infusion reactions and infections. Patients should be monitored during the infusion and for at least 1 hour after each one for signs and symptoms of an infusion reaction, which can include: itchy skin, rash, hives, tiredness, coughing or wheezing, trouble breathing, throat irritation or pain, feeling faint, fever, redness on the face (flushing), nausea, headache, swelling of the throat, dizziness, shortness of breath, fatigue, and rapid heartbeat.

Citation:

FDA approves Genentech’s OCREVUS™ (ocrelizumab) for relapsing and primary progressive forms of multiple sclerosis [news release]. San Francisco, CA: Genentech March 28, 2017. https://www.gene.com/media/press-releases/14657/2017-03-28/fda-approves-genentechs-ocrevus-ocrelizu. Accessed March 29, 2017.