EMA and FDA accept for review Roche’s Ocrevus for two forms of multiple sclerosis

Roche’s marketing authorization application of the drug has been validated by the EMA to treat relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), confirming that the submission is complete and under review by the agency’s Committee for Medicinal Products for Human Use.

The FDA has also accepted for review and granted priority review designation to the company’s biologics license application for Ocrevus to treat the same two conditions. Its action date is 28 December 2016.

Ocrevus is a humanised monoclonal antibody that selectively targets CD20-positive B cells, a specific type of immune cell believed to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage.

In three phase III studies, Ocrevus met primary and key secondary endpoints.

Roche chief medical officer and head of global product development Sandra Horning said: "Ocrevus is the first investigational medicine to significantly reduce disability progression in people with relapsing and primary progressive forms of MS.

"We are pleased by the acceptance of our marketing applications for Ocrevus, which we believe has the potential to help people living with either of these two forms of MS.

Roche claims that if approved will be the first and only treatment indicated for both forms of MS, which affect about 95% of people at diagnosis.

The company has recently submitted regulatory applications for Ocrevus in Switzerland and Australia.

Image: Site Roche Basel. Photo: courtesy of F. Hoffmann-La Roche Ltd.