ocrelizumab infusion drip

Breakthrough for ocrelizumab

American drug regulators have granted ocrelizumab a special status that could speed up approval following positive phase three trial results.

Ocrelizumab has been given Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA). This status exists to speed up the development and review of medicines intended to treat serious or life-threatening diseases. Fast tracking the approval process helps to ensure people have access through the US drug approval pathway as soon as possible.

The process

The timing of any final approval is not yet known but once the FDA grants ocrelizumab a license this means it will be available for doctors to prescribe in the US. Though the UK is part of a separate licensing process in Europe this is still a significant step forward in the development of ocrelizumab.

Strong evidence base 

The Breakthrough Therapy Designation has been granted based on top line results presented in October 2015 by pharmaceutical company Roche.

Ocrelizumab is the first treatment that has shown positive results in a phase three clinical trial for people with primary progressive MS. Treatment with ocrelizumab led to a reduction in the progression of clinical disability by 24% compared to placebo. This reduction was sustained for at least 12 weeks and was measured by the Expanded Disability Status Scale (EDSS). In relapsing remitting MS ocrelizumab reduced the number of relapses, by 46% in one trial and 47% in another, compared to Rebif.

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