FDA fast-tracks review of Roche’s potential MS blockbuster

The US regulator is to review Roche’s ocrelizumab multiple sclerosis drug, widely tipped to be a blockbuster.

Its Genentech unit said the US Food and Drug Administration had granted a six-month priority review for both relapsing multiple sclerosis and primary progressive multiple sclerosis.

The FDA is due to make a decision before 28 December this year, and the European Medicines Agency is also reviewing the drug, which will have the brand name Ocrevus.

If approved for both indications, Ocrevus would be the first and only treatment indicated for both forms of MS, which affect approximately 95% of people at diagnosis.

It is this dual indication, including primary progressive MS, which is expected to push sales into the billions.

The FDA grants priority reviews to drugs determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment of a serious disease.

Ocrevus had previously been granted the Breakthrough Therapy designation, given to the most promising new drugs, becoming the first investigational medicine to be granted the status in MS.

Filings are based on positive results from three phase 3 studies, which met primary and secondary endpoints.

Data from two identical studies (OPERA I and OPERA II) in people with RMS showed superior efficacy of Ocrevus in reducing annualised relapse rates and disability progression sustained for at least three and for at least six months compared with Merck KGaA’s rivalRebif (interferon beta-1a).

Data from the ORATORIO study in people with PPMS showed significant reductions in disability progression sustained for at least three and for at least six months, as well as in as other measures of progressive disease compared with placebo.

Overall safety (proportion of patients with adverse events and serious adverse events) of Ocrevus in the Phase 3 studies was similar to interferon beta-1a in the RMS studies and to placebo in the PPMS study. The most common adverse events associated with Ocrevus were infusion-related reactions and infections, which were mostly mild to moderate in severity.

Ocrevus is a humanised monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with MS.

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