FDA approves ocrelizumab

March 29, 2017
The U.S. Food and Drug Administration approved Ocrevus (ocrelizumab), made by Genentech, to treat adult patients with relapsing forms of multiple sclerosis and primary progressive multiple sclerosis. This is the first drug approved by the FDA for PPMS. Ocrevus is an intravenous infusion given by a health care professional every six months.
 
The efficacy of Ocrevus for the treatment of relapsing forms of MS was shown in two clinical trials in 1,656 participants treated for 96 weeks. Both studies compared Ocrevus to another MS drug, Rebif (interferon beta-1a). In both studies, the patients receiving Ocrevus had reduced relapse rates and reduced worsening of disability compared to Rebif.
 
In a study of PPMS in 732 participants treated for at least 120 weeks, those receiving Ocrevus showed a longer time to the worsening of disability compared to placebo.
 
Ocrevus should not be used in patients with hepatitis B infection or a history of life-threatening infusion-related reactions to Ocrevus. Ocrevus must be dispensed with a patient medication guide that describes important information about the drug’s uses and risks. Ocrevus can cause infusion-related reactions, which can be serious. These reactions 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. Additionally, Ocrevus may increase the risk for malignancies, particularly breast cancer. Delay Ocrevus treatment for patients with active infections. Vaccination with live or live attenuated vaccines is not recommended in patients receiving Ocrevus.
 
In addition to the infusion-related reactions, the most common side effect of Ocrevus seen in the clinical trials for relapsing forms of MS was upper respiratory tract infection. The most common side effects in the study of PPMS were upper respiratory tract infection, skin infection, and lower respiratory tract infection. There may be an increased risk of malignancy in people taking Ocrevus.
 
Ocrevus will be available to people in the U.S. within two weeks. Genentech will be offering comprehensive services for people prescribed Ocrevus to help minimize barriers to access and reimbursement. Patients can call 844-OCREVUS for more information. For people who qualify, Genentech plans to offer patient assistance programs through Genentech Access Solutions. More information is also available at 866-4ACCESS (866-422-2377) or www.Genentech-Access.com.

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