EMA recommends approval of Roche's Ocrevus in relapsing forms of multiple sclerosis

Roche has revealed that its humanised monoclonal antibody Ocrevus (ocrelizumab) received a positive recommendation from the Committee for Medical Products for Human Use (CHMP) in the treatment of active relapsing forms of multiple sclerosis.

The consensus was reached on the drug’s efficacy thanks to data from three Phase 3 studies in which it hit all primary and secondary endpoints. Amongst these data, it was found that Ocrevus was able to reduce the number of attacks per year by almost 50% and significantly slowed disease progression over two years of study compared to a high dose regimen of Rebif (interferon beta-1a).  

In addition, it was found that patients taking the drug were significantly less likely to have any evidence of disease activity, including the number of patients with no sign of disease activity. These findings solidify Ocrevus as the first and only drug with this capability and potential .

A full approval for Roche’s therapy is expected from the EMA in the coming weeks. The drug is already approved in a number of countries including South America , Australia, Spain and the Middle East.  

"Today’s positive recommendation for Ocrevus is great news for people in Europe with active relapsing forms of MS as well as those with early primary progressive MS, who are all now one step closer to having  this important new treatment option,’’ aid Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development. "We are pleased that the CHMP has recognised the clinical significance of the Ocrevus data, particularly for people living with primary progressive MS, a highly disabling disease that currently has no approved treatments in Europe.’’