First disease modifying therapy for primary progressive MS
U.S. FDA approved Ocrevustm (ocrelizumab) for people with primary progressive MS or relapsing MS
The U.S. Food and Drug Administration has approved Ocrevustm (ocrelizumab – Genentech, a member of the Roche Group) 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 labeling 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”
The FDA granted Priority Review Designation based on criteria indicating that the drug, if approved, would be a significant improvement in the safety or effectiveness compared to standard treatments.
Ocrevus is currently being reviewed by the European Medicines Agency (EMA), the body responsible for drug licensing in Europe. A decision is expected later this year. The US decision came earlier because Ocrevus was granted priority review status, which speeds up the licensing process. The EMA does not have a priority review system.
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.