FDA Approves Subcutaneous Ocrevus for Multiple Sclerosis

The FDA has approved a subcutaneous form of Genentech’s Ocrevus to treat patients with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) was approved as a twice-a-year, approximately 10-minute subcutaneous injection to be administered by a healthcare practitioner.

Ocrevus Zunovo will be available in a few weeks and be priced at parity with the Ocrevus IV.

This is the second approval in two days for subcutaneous formulations of Genentech’s previously approved products.

“People are living longer with chronic illnesses and with fewer disabilities because of the extensive progress that has been made in the development of medicines that can slow their progression,” Natalie Blake, executive director of the MS Foundation, said in a news release. “But still, not everyone has access to these medicines. It’s crucial to acknowledge each experience with MS is as unique as the individual navigating it, so providing choices to address each person’s needs is essential.”

Ocrevus was first approved as an intravenous injection. It is a humanized monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin and nerve cell damage. The current list price of Ocrevus is $78,858 annually.

Genentech offers a copay program for $0 a treatment for eligible commercially insured patients with a limit of $20,000 per calendar year. The terms say that Genentech may cap the assistance if “Genentech determines that a third party has implemented a program that adjusts patient cost-sharing obligations based on the availability of support under the Program and/or excludes the assistance provided under the program from counting towards the patient’s deductible or out-of-pocket cost limitations.”

Ocrevus Zunovo combines Ocrevus with Halozyme Therapeutics’ Enhanze drug delivery technology.

The FDA approval of Ocrevus Zunovo is based on pivotal data from the phase 3 OCARINA II trial, which enrolled 236 patients and showed no clinically significant difference in the levels of Ocrevus in the blood when administered subcutaneously. The safety and efficacy profile are consistent with the IV formulation in people with RMS and PPMS.

Of the exploratory outcomes measured, Ocrevus Zunovo was consistent with IV, demonstrating suppression of relapse activity (97%) and MRI lesions (97%) through 48 weeks. Additionally, more than 92% of trial participants reported being satisfied or very satisfied with the subcutaneous administration of Ocrevus Zunovo.

“Patients treated with subcutaneous Ocrevus experienced appropriate B-cell suppression and impressive near-complete suppression of new inflammatory disease activity,” Scott Newsome, D.O., lead author, Johns Hopkins University School of Medicine, said in a previous news release. These results demonstrate the potential of subcutaneous Ocrevus as a treatment option that can be matched to the individual needs of people with MS and healthcare professionals.”