Roche's OCREVUS Trial Confirms Standard Dose as Optimal

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its Phase III MUSETTE trial—which tested a higher dose of OCREVUS® (ocrelizumab) against the currently approved 600 mg dose in relapsing multiple sclerosis (RMS)—did not show additional benefit in slowing disability progression. The study followed patients for at least 120 weeks, and results confirmed that the standard 600 mg dose remains the optimal choice.

While the high-dose version didn’t improve disability outcomes, OCREVUS 600 mg continued to show strong results in reducing disease activity. Notably, predefined analyses revealed that patients on this dose had the lowest annualized relapse rate (ARR) ever recorded in a Phase III RMS trial, with relapses occurring approximately once every 16 years—a significant milestone for an anti-CD20 MS therapy.

Why This Matters for Patients

“OCREVUS is the first and only B-cell therapy approved for both RMS and primary progressive multiple sclerosis (PPMS). After more than a decade of use, most people with RMS remain free from disease progression,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer. “These findings reaffirm that the 600 mg dose is the right choice for significantly slowing disability. The strong relapse data further highlight its impact in controlling the disease.”

Expanding Access and Future Innovations

Since its approval, OCREVUS has transformed MS treatment, becoming the most prescribed disease-modifying therapy (DMT) in the U.S., with over 400,000 people treated worldwide. Roche recently launched a subcutaneous version of OCREVUS, designed to make treatment more accessible for people who may not have easy access to IV infusions. The company is also developing a high-concentration formulation for a potential on-body device, aiming to make treatment even more convenient for patients.

Beyond OCREVUS, Roche is advancing several new treatments for multiple sclerosis, including:

• Brainshuttle™ CD20, designed to enhance drug delivery to the brain

• MAGL inhibitor, targeting neuroinflammation

• Fenebrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor currently in Phase III trials for both RMS and PPMS