OCREVUS (Ocrelizumab), the First DMT for Primary Progressive MS Approved by the FDA

OCREVUS (Ocrelizumab), the First DMT for Primary Progressive MS Approved by the FDA

The US Food and Drug Administration (FDA) has approved Genentech’s new MS treatment, OCREVUS (ocrelizumab), for the treatment of primary progressive and relapsing multiple sclerosis. Ocrevus is now the first and only disease-modifying treatment (DMT) approved for primary progressive MS.

Clinical Trials

The efficacy and safety of Ocrevus were evaluated in multiple Phase 3 clinical trials. The ORATORIO study evaluated the efficacy and safety of Ocrevus in people with primary progressive MS. Two identical studies (OPERA I and OPERA 2) examined the treatment of Ocrevus in people with RRMS.

In the ORATORIO study, Ocrevus significantly slowed disability progression and reduced signs of disease activity in the brain (measured by MRI) compared with placebo. The proportion of people who experienced adverse events was similar between those receiving Ocrevus and those receiving placebo.

In OPERA I and OPERA II, Ocrevus demonstrated superior efficacy compared with Rebif in reduction in annualized relapse rate (ARR), slowing the worsening of disability, and reducing MRI lesions. In both OPERA I and OPERA 2, a similar proportion of people who received Ocrevus experienced a low rate of serious adverse events and serious infections compared with those who received Rebif.

Across all Phase 3 studies, the most common side effects associated with treatment with Ocrevus were infusion reactions and upper respiratory tract infections.

Currently there have been no cases of progressive multifocal leukoencephalopathy (PML) reported in people treated with Ocrevus, but it is a possibility. PML is a rare brain infection that usually leads to death or severe disability.

What is Ocrevus and how is it taken?

Ocrevus is a humanized monoclonal antibody that selectively targets CD20-positive B cells, which is a specific type of immune cell that is thought to contribute to myelin and axonal damage. It is taken by intravenous (IV) infusion every 6 months; the first dose is given as two 300 mg infusions taken 2 weeks apart, and subsequent doses are given as single 600 mg infusions.

The approval of Ocrevus is an important milestone in the treatment of MS, especially for those with PPMS. For more information about Ocrevus, go to http://www.OCREVUS.com.1-3

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