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News and Opinions about MS, Health & Disability

Drug ´breakthrough´ for primary progressive MS

on May 25, 2016

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Everyone living with primary progressive multiple sclerosis should be excited by the fact a drug being developed for treatment of that particular type of MS has been given ´breakthrough´ designation by the USA´s Food and Drug Administration (FDA).

The special status means that the drug, called ocrelizumab, could be approved more quickly following positive phase three trial results.

Breakthrough Therapy Designation 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 timing of any final approval is not yet known but once the FDA grants ocrelizumab a licence 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.

The ´breakthrough designation has been granted based on top line results presented by pharmaceutical company Roche.

Ocrelizumab is the very first treatment to have 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 when compared to Rebif.


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