European Medicines Agency approves first disease-modifying therapy for primary progressive MS
European Medicines Agency approves Ocrevus for people with primary progressive MS or relapsing MS
11 January 2018
The European Medicines Agency (EMA) has approved Ocrevus (ocrelizumab) for use in the treatment of primary progressive MS and relapsing MS, making it the first therapy for the treatment of primary progressive multiple sclerosis. Ocrevus will be available as a first-line treatment, which means that there are no recommendations in the approved labelling for people to try other MS therapies before taking it. Ocrevus has not been tested in children.
“One cannot under-estimate the importance and impact of the very first treatment for primary progressive MS - this is the crucial first step in finding ever more effective treatments for everyone with progressive MS and approvals of this treatment by various regulatory bodies throughout the world demonstrate important momentum to progress.”
The EMA Committee for Medicinal Products for Human Use (CHMP) recommended granting a marketing authorisation in the European Union (EU) for Ocrevus in November 2017. The U.S Federal Drug Administration (FDA) and regulatory bodies in Switzerland and Australia approved Ocrevus as a treatment of primary progressive MS and relapsing MS in 2017.
The Alliance continues to assess all potential areas of progress and increased understanding, while bringing the world together to accelerate the development of treatment for everyone living with progressive MS.
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