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Degenerative neurological disorders

FDA approves first drug for progressive multiple sclerosis

The US Food and Drug Administration (FDA), which is responsible for evaluating the safety and efficacy of medicines in the United States, has approved the use of ocrelizumab (Ocrevus; Genentech) for adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS).

“MS can have a profound impact on a person’s life,” says Billy Dunn, 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,” he adds.

A lack of understanding as to the underlying biology of PPMS, means that there are currently no effective treatments to halt its advance, unlike the relapsing form of the illness for which several drugs are currently approved.

Ocrelizumab is a humanised monoclonal antibody administered as an intravenous infusion every six months. It works by targeting CD20-positive B cells, a type of immune cell thought to be involved in the abnormal immune response that attacks the myelin coating of nerve cells.

Its efficacy against relapsing forms of MS was determined through two clinical trials where 1,656 patients were treated for a total of 96 weeks. Ocrelizumab was compared with another MS drug, 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.

To assess its effectiveness as a treatment for PPMS, 732 participants were treated for a minimum of 120 weeks. Again, ocrelizumab showed a reduced worsening of disability compared with placebo.

Ocrelizumab must not be used in patients with a history of hepatitis B infection or life-threatening infusion-related reactions to ocrelizumab. These reactions can include itchy skin, rash, hives, skin redness, shortness of breath and a fast heartbeat.

Ocrelizumab was accepted for review by the European Medicines Agency on 30 June 2016 and a decision is expected in autumn 2017.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20202543

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