FDA Approves Roche's Subcutaneous OCREVUS ZUNOVO™ with ENHANZE® for MS

Halozyme Therapeutics, Inc. has announced that Roche has received approval from the U.S. Food and Drug Administration (FDA) for OCREVUS ZUNOVO™ (ocrelizumab and hyaluronidase-ocsq). This treatment, which includes Halozyme's ENHANZE® drug delivery technology, is designed for patients with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). OCREVUS ZUNOVO™ offers a new twice-a-year, approximately 10-minute subcutaneous (SC) injection that can be administered by healthcare professionals.

Dr. Helen Torley, President and CEO of Halozyme, expressed her satisfaction with the approval, emphasizing that OCREVUS ZUNOVO™ provides greater flexibility and options for multiple sclerosis patients and their healthcare providers. The FDA's decision was based on the pivotal data from the Phase III OCARINA II trial. This trial demonstrated that OCREVUS ZUNOVO™ achieved non-inferior levels of OCREVUS in the bloodstream when administered subcutaneously, maintaining a safety and efficacy profile that was comparable to the intravenous (IV) formulation for patients with RMS and PPMS.

The OCARINA II trial also reported that the most common adverse effects of OCREVUS ZUNOVO™ were injection reactions, all of which were either mild or moderate and did not result in treatment withdrawal. The trial's exploratory outcomes revealed that OCREVUS ZUNOVO™ was consistent with the IV formulation in suppressing relapse activity and MRI lesions, both standing at 97% through 48 weeks. Additionally, more than 92% of participants reported being satisfied or very satisfied with the SC administration of OCREVUS ZUNOVO™.

Halozyme Therapeutics is dedicated to advancing patient care through innovative solutions. The company’s ENHANZE® drug delivery technology, based on the proprietary enzyme rHuPH20, facilitates the subcutaneous administration of drugs, aiming to improve the patient experience by enabling rapid delivery and reducing the treatment burden. Halozyme's technology has impacted over 800,000 patients globally through eight commercialized products available in more than 100 markets. The company has partnerships with several leading pharmaceutical and biotechnology firms, including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical, and Acumen Pharmaceuticals.

Beyond its ENHANZE® technology, Halozyme also develops and markets drug-device combination products that enhance convenience, reliability, and patient adherence. These products include its commercial proprietary offerings, Hylenex® and XYOSTED®, as well as partnered commercial products and ongoing development programs with companies such as Teva Pharmaceuticals and Idorsia Pharmaceuticals.

Halozyme is headquartered in San Diego, California, with additional offices in Ewing, New Jersey, and Minnetonka, Minnesota. The Minnetonka site also houses the company's operations facility.

OCREVUS ZUNOVO™ stands as a promising new treatment option for multiple sclerosis patients, especially those in centers without the infrastructure for intravenous treatments. The FDA's approval marks a significant milestone in providing more accessible and flexible care for RMS and PPMS patients.