Roche Receives U.S. FDA Approval for Ocrelizumab's Two-Hour Infusion Time

   By Giulia Petroni

Roche Holding AG said late Monday that the U.S. Food and Drug Administration approved a shorter, two-hour infusion time for ocrelizumab for the treatment of relapsing and primary progressive multiple sclerosis.

The Swiss pharmaceutical company said the approval was based on data from the randomized, double-blind "Ensemble Plus" study.

Earlier this year, the drug's two-hour infusion time was approved by the European Medicines Agency.

"More than 170,000 people with multiple sclerosis have been treated with Ocrevus, the only approved B-cell therapy with a twice-yearly dosing schedule," said Levi Garraway, Roche's chief medical officer and head of global product development, referring to the drug by its brand name.

Write to Giulia Petroni at giulia.petroni@wsj.com

(END) Dow Jones Newswires

December 15, 2020 02:22 ET (07:22 GMT)

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