FDA Approves Ocrevus Zunovo™: First Twice-Yearly 10-Minute Injection for MS

Genentech, part of the Roche Group, announced that the U.S. FDA has approved Ocrevus Zunovo™ (ocrelizumab & hyaluronidase-ocsq) for treating relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Ocrevus Zunovo is the first twice-yearly, 10-minute subcutaneous injection administered by healthcare professionals, offering more treatment options for people with MS.

Genentech, part of the Roche Group, announced that the FDA has approved Ocrevus Zunovo™ (ocrelizumab & hyaluronidase-ocsq) for relapsing and primary progressive multiple sclerosis (MS). This new option provides a twice-yearly, 10-minute subcutaneous injection administered by healthcare professionals.

Dr. Levi Garraway, Genentech’s Chief Medical Officer, highlighted that this approval builds on the proven safety and efficacy of Ocrevus, offering greater flexibility for healthcare providers and patients. Natalie Blake from the MS Foundation emphasized the importance of providing more treatment options for people with MS.

Ocrevus Zunovo, based on the Phase III OCARINA II trial, showed similar efficacy and safety to the IV version, reducing relapses and MRI lesions. The trial reported high patient satisfaction, with most participants experiencing only mild to moderate injection reactions. Genentech remains committed to expanding MS research and improving treatment options for those living with the disease.

Ocrevus Zunovo is designed to target CD20-positive B cells, a key contributor to MS progression. It combines Ocrevus with Halozyme’s Enhanze® technology, enhancing subcutaneous drug absorption. Ocrevus and Ocrevus Zunovo are the only FDA-approved therapies for both relapsing and primary progressive MS.

MS affects over 2.9 million people globally, causing progressive nerve damage and disability. Early treatment is critical to slow disease progression. Genentech continues to focus on neuroscience research, advancing treatments for neurological disorders like MS, Alzheimer’s, and Parkinson’s. Through their Access Solutions program, Genentech also helps ensure patients can access necessary treatments, regardless of their financial situation.

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