FDA Approves the First and Only Twice-A-Year 10-Minute Subcutaneous Injection for People with Relapsing and Progressive Multiple Sclerosis
September 13th, 2024
On September 13, 2024, the FDA approved Ocrevus Zunovo™ (ocrelizumab and hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) in adults.
News in brief
- Ocrevus Zunovo is the first and only twice-a-year, healthcare professional (HCP)-administered, approximately 10-minute subcutaneous injection approved for both relapsing and primary progressive forms of MS.
- The approval is based on the consistent pharmacokinetic exposure data from the Phase III OCARINA II trial, which showed no clinically significant difference in exposure between Ocrevus Zunovo and Ocrevus IV.
- The approval is further backed by a decade of proven safety and efficacy data for Ocrevus IV, with over 350,000 people treated globally.
- The safety profile of Ocrevus Zunovo was consistent with the well-established safety profile of Ocrevus IV, with the exception of injection reactions.
- Genentech is dedicated to advancing innovative clinical research programs to broaden the scientific understanding of multiple sclerosis, further reducing disability progression in RMS and PPMS and improving the treatment experiences for those living with the disease.
Supporting Information
“Ocrevus Zunovo gives patients and providers another option for receiving Ocrevus, building on a decade of robust safety and efficacy data for Ocrevus in multiple sclerosis. Today’s approval may offer greater flexibility for healthcare providers and people living with multiple sclerosis, based on their individual treatment needs.”