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# Ocrevus IV Phase 3 Study Misses Primary Endpoint
- URL: https://www.fdaweb.com/ocrevus-iv-phase-3-study-misses-primary-endpoint/
- Published: 2025-04-02T12:00:00.000Z
- Updated: 2026-09-14T14:56:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158940

Roche says the Phase 3 MUSETTE trial evaluating whether a higher dose of the approved Ocrevus IV 600 mg would provide additional benefit to people living with relapsing multiple sclerosis failed to meet its primary endpoint. A company [statement](https://www.roche.com/media/releases/med-cor-2025-04-02?ref=fdaweb.com) says the trial results support Ocrevus IV 600 mg as the optimal dose to slow disability progression.

“The high dose was well tolerated with an overall comparable safety profile to Ocrevus IV 600 mg and no new safety signals observed,” Roche says. “These data further support the efficacy and safety profile of Ocrevus IV 600 mg dose for relapsing multiple sclerosis.”

Ocrevus is described as a humanized monoclonal antibody designed to target CD20-positive B cells, a specific type of cell thought to be a key contributor to myelin and axonal damage that can lead to disability in people with multiple sclerosis.