FDA clears Roche's multiple sclerosis therapy Ocrevus

The FDA approved Roche's Ocrevus (ocrelizumab) as the first medicine for both relapsing and primary progressive forms of multiple sclerosis, the company announced. The agency had extended its review of Ocrevus in December last year following the submission of additional data regarding the drug's commercial manufacturing process.

Sandra Horning, Roche's chief medical officer, said the approval "represents a significant scientific advance with this first-in-class B-cell targeted therapy," adding "we believe Ocrevus, given every six months, has the potential to change the disease course for people with MS." Analysts predict that the product, which is currently under regulatory review in Europe, could generate annual sales of more than $3 billion by 2021.

Roche said that it will set the price of Ocrevus at $65 000 per year, which spokesman Ed Lang noted represents a 25-percent discount to Merck KGaA's Rebif (interferon beta-1a). "Multiple sclerosis medicines, on average, cost almost four times more today than they did 12 years ago. We feel the industry needs to start to reverse this trend," remarked Lang. For related analysis, read ViewPoints: Roche fronts up with Ocrevus pricing power.

FirstWord reports in this therapy area - KOL Insight Multiple Sclerosis: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.

In two Phase III studies, Ocrevus demonstrated superior efficacy on the three major markers of disease activity by reducing relapses per year by nearly half, slowing the worsening of disability and significantly reducing MRI lesions compared with Rebif over the two-year controlled treatment period. Meanwhile, in another late-stage trial in patients with primary progressive multiple sclerosis, Roche's drug significantly slowed disability progression and reduced signs of disease activity in the brain compared with placebo with a median follow-up of three years.

Ocrevus, a humanised monoclonal antibody designed to selectively target CD20-positive B cells, is administered by intravenous infusion every six months. The first dose is given as two 300 mg infusions given two weeks apart, while subsequent doses are given as single 600 mg infusions.


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