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

Genentech, a member of the Roche Group, has received approval from the U.S. FDA for Ocrevus Zunovo™ (ocrelizumab & hyaluronidase-ocsq) for treating relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). This new formulation is the first and only twice-yearly subcutaneous injection, administered by healthcare professionals, approved for both types of MS, providing patients with additional treatment options.

Ocrevus Zunovo offers a more flexible administration method, potentially expanding treatment accessibility to centers without IV infrastructure. Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer, emphasized that this approval builds on a decade of robust safety and efficacy data for Ocrevus. Natalie Blake, Executive Director of the MS Foundation, highlighted the importance of providing diverse treatment options to accommodate the unique experiences of MS patients.

The treatment process for Ocrevus Zunovo is streamlined, with the initial dose time being as short as 55 minutes. Patients must take premedications at least 30 minutes before each dose and are monitored for at least 60 minutes after the first dose and 15 minutes after subsequent doses.

The FDA's decision was based on data from the Phase III OCARINA II trial, which demonstrated comparable levels of Ocrevus in the blood when administered subcutaneously versus intravenously, maintaining similar safety and efficacy profiles. In the trial, 97% of participants experienced consistent suppression of relapse activity and MRI lesions over 48 weeks. Additionally, over 92% of the participants reported satisfaction with the subcutaneous administration method.

While the safety profile of Ocrevus Zunovo was largely consistent with the IV formulation, injection reactions were more common, particularly with the first injection. These reactions were generally mild to moderate and did not lead to treatment discontinuation.

Genentech continues to advance its clinical research to further understand MS and improve treatment experiences. The company is conducting more than 30 ongoing MS clinical trials. Developing new formulations like Ocrevus Zunovo aligns with their commitment to enhancing patient experiences and addressing diverse needs.

Ocrevus Zunovo combines Ocrevus with Halozyme Therapeutics’ Enhanze® drug delivery technology. Ocrevus targets CD20-positive B cells, crucial in myelin and nerve cell damage associated with MS. The Enhanze technology enables rapid dispersion and absorption of Ocrevus into the bloodstream by temporarily increasing tissue permeability under the skin.

Ocrevus and Ocrevus Zunovo remain the only therapies approved for RMS and PPMS, including various MS forms such as relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS). The OCARINA II study, a Phase III global trial, confirmed the non-inferiority of the subcutaneous formulation compared to the IV infusion in controlling clinical and radiological disease activity.

Multiple sclerosis is a chronic disease affecting over 2.9 million people globally. It involves the immune system attacking the myelin sheath in the central nervous system, leading to symptoms like weakness, fatigue, and vision difficulties. MS progression occurs from disease onset, even if symptoms are not immediately apparent, emphasizing the need for early diagnosis and treatment to prevent disability.

Relapsing-remitting MS is the most common form, affecting about 85% of MS patients initially. This form is marked by episodes of worsening symptoms followed by recovery periods. Many RRMS patients eventually transition to secondary progressive MS, characterized by a steady increase in disability. Primary progressive MS affects approximately 15% of MS patients and is marked by continuous symptom worsening without distinct relapses.

Genentech is committed to advancing neuroscience research, developing treatments to improve lives affected by chronic neurological diseases, including MS. The company is investigating various neurological disorders and working with partners to push scientific boundaries in this field.

By offering Ocrevus Zunovo, Genentech provides a new, flexible treatment option for MS patients, reflecting its dedication to innovation and patient care.