Roche Holding AG (RO.EB) said Friday that a European Medicines Agency committee gave a positive opinion on its multiple-sclerosis drug, marking an important step toward EU approval.
The Committee for Medicinal Products for Human Use, or CHMP, recommended a marketing authorisation be granted for Ocrevus to be used as a treatment for relapsing and primary-progressive forms of the disease, after the drug performed well in phase-three trials.
Roche said it expects a final decision on marketing approval from the European Commission within the next few months. If approved, Ocrevus will be the first and only medicine for people in the European Union with primary-progressive multiple sclerosis, the company said.
Ocrevus is already approved for use in Switzerland and the U.S.
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(END) Dow Jones Newswires
November 10, 2017 08:58 ET (13:58 GMT)