Roche's OCREVUS® SC with ENHANZE® Approved in Europe for Multiple Sclerosis

Halozyme Therapeutics, Inc. has announced that the European Commission has granted marketing authorization for OCREVUS® (ocrelizumab) subcutaneous (SC) injection, co-formulated with Halozyme’s proprietary enzyme ENHANZE® (rHuPH20), for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). This new formulation allows for a 10-minute administration, offering an alternative to the intravenous (IV) infusion that requires more time and specialized facilities.

The SC injection of OCREVUS® can be administered by healthcare professionals either in clinical settings or other convenient locations, providing significant flexibility for both patients and medical providers. Dr. Helen Torley, CEO of Halozyme, emphasized that this method enables patients to receive their medication quickly and without the necessity of IV facilities, thereby improving accessibility and convenience.

The European Commission's approval was grounded in data from the Phase III OCARINA II trial. The trial demonstrated that the SC injection had non-inferior blood levels of OCREVUS® compared to the IV infusion. Additionally, the safety and efficacy profiles were comparable between the two methods for patients with RMS and PPMS. The SC injection was well tolerated, and no new safety issues emerged during the trial.

Halozyme Therapeutics is a biopharmaceutical company known for advancing treatments that improve patient experience and outcomes. ENHANZE® technology, featuring the proprietary enzyme rHuPH20, facilitates subcutaneous delivery of injected drugs, making treatments easier and more manageable for patients. ENHANZE® has been used in over 800,000 patients globally, across seven commercialized products in more than 100 markets. The technology is licensed to several major pharmaceutical companies, including Roche, Takeda, Pfizer, Janssen, AbbVie, and Eli Lilly, among others.

Apart from its collaborations, Halozyme also develops and commercializes drug-device combination products that provide benefits such as convenience, reliability, and improved patient adherence. The company’s proprietary products include Hylenex® and XYOSTED®, and it has ongoing product development programs with pharmaceutical partners like Teva Pharmaceuticals and Idorsia Pharmaceuticals.

Halozyme is headquartered in San Diego, California, with additional offices in Ewing, New Jersey, and Minnetonka, Minnesota, which also houses its operations facility. The company is committed to enhancing patient care through innovative drug delivery solutions and continues to expand its global footprint through strategic partnerships and product developments.