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FDA Approves Ocrevus, a New Treatment for MS

March 29, 2017
Intravenous infusion is designed to decrease number of relapses in multiple sclerosis (MS) and worsening function in patients with primary progressive MS.

There is a new treatment for patients with relapsing multiple sclerosis (MS) and primary progressive MS. The US Food and Drug Administration (FDA) announced the approval of Ocrevus (ocrelizumab, Genentech). This intravenous infusion is the first new treatment for primary progressive MS, according to a press release from the FDA.

For most people with MS, episodes of relapses are followed by remissions. Primary progressive MS is characterized by steadily worsening function from the onset of symptoms, often without early relapses or remissions. The US Centers for Disease Control and Prevention estimates that approximately 15% of patients with MS have primary progressive MS.

“Multiple sclerosis can have a profound impact on a person’s life,” said Billy Dunn, MD, director of the Division of Neurology Products in 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.”

Efficacy Data

New infusion treatment, Ocrevus from Genetech, for relapsing and primary progressive multiple sclerosis.The efficacy of ocrelizumab for the treatment of relapsing forms of MS was demonstrated in 2 clinical trials, which included 1,656 participants treated for 96 weeks (2 years). Both studies compared ocrelizumab with another drug approved for MS, interferon beta-1a (Rebif). In both studies, the patients receiving ocrelizumab had reduced relapse rates and reduced worsening of disability compared with interferon beta-1a. In a study of primary progressive MS, 732 participants were treated for at least 120 weeks. Those who received ocrelizumab showed a longer time to the worsening of disability compared with patients given placebo.

The new agent is not without side effects. According to the agency, ocrelizumab should not be used in patients with hepatitis B infection or a history of life-threatening infusion-related reactions to ocrelizumab. In addition, ocrelizumab may increase the risk for malignancies, particularly breast cancer. As part of its safety program, ocrelizumab must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.

Ocrelizumab 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,” noted a press release from the FDA. Delay ocrelizumab treatment for patients with active infections. Vaccination with live or live attenuated vaccines is not recommended in patients receiving ocrelizumab.

In addition to the infusion-related reactions, the most common side effect of ocrelizumab 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.

The FDA granted this application breakthrough therapy designation, fast track designation, and priority review.

Last updated on: March 29, 2017
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