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
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 email@example.com
(END) Dow Jones Newswires
December 15, 2020 02:22 ET (07:22 GMT)
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