Roche Gets FDA Approval for Multiple-Sclerosis Treatment

Dow Jones09-14

By Connor Hart

Roche Holding's Genentech unit said the Food and Drug Administration approved its twice-yearly, subcutaneous injection treatment for patients with two types of multiple sclerosis.

The treatment, called Ocrevus Zunovo, was approved as a biannual, approximately 10-minute, under-the-skin injection for patients with relapsing multiple sclerosis and primary progressive multiple sclerosis. Administered by a healthcare practitioner, the treatment contains drug-delivery technology developed by San Diego biopharmaceutical company Halozyme.

The approval is based on data from a phase 3 trial that showed no clinically significant difference in the levels of Ocrevus in patients' blood from the intravenous formulation, as well as a comparable safety and efficacy profile.

Write to Connor Hart at connor.hart@wsj.com

(END) Dow Jones Newswires

September 13, 2024 14:31 ET (18:31 GMT)

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