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Home Industry News Roche receives CHMP backing for multiple sclerosis therapy Ocrevus

Roche receives CHMP backing for multiple sclerosis therapy Ocrevus

14th November 2017

Roche has announced that its new multiple sclerosis therapy Ocrevus has been recommended for European regulatory approval.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion for the use of Ocrevus for people with active relapsing forms of multiple sclerosis and for early primary progressive multiple sclerosis.

This decision was based on data from three pivotal phase III studies, which showed that the drug delivered superior efficacy on reducing the number of disease relapses and significantly slowed progression of the condition compared with high-dose interferon beta-1a therapy.

Based on this positive CHMP opinion, a final decision from the European Commission regarding the approval of Ocrevus is expected in the coming months.

Dr Sandra Horning, Roche's chief medical officer and head of global product development, said: "We are pleased that the CHMP has recognised the clinical significance of the Ocrevus data, particularly for people living with primary progressive multiple sclerosis, a highly disabling disease that currently has no approved treatments in Europe."

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