FDA Approves Ocrevus Zunovo for 2 Forms of Multiple Sclerosis

The FDA approved ocrelizumab and hyaluronidase-ocsq (Ocrevus Zunovo; Genentech) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The approval marks the first and only twice yearly, health care professional-administrated subcutaneous (SC) injections for both forms of MS.¹

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“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," Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Genentech, said in a news release.¹

The FDA approval is based on pivotal data from the phase 3 OCARINA II (NCT05232825) trial, which demonstrated no clinically significant difference in the levels of ocrelizumab and hyaluronidase-ocsq in the blood when administered SC. Further the safety and efficacy profile were consistent to the intravenous (IV) formulation for the patient populations.¹

Investigators included patients aged 18 to 65 years, who had a an Expanded Disability Status Scale score of 0 to 6.5. Treatment was randomized by ocrelizumab and hyaluronidase-ocsq 600 mg intravenously or 920 mg ocrelizumab and hyaluronidase-ocsq SC. The outcomes included comparison of serum ocrelizumab and hyaluronidase-ocsq area under the concentration-time curve from baseline to week 12, according to the study authors. Other end points included magnetic resonance imaging (MRI) lesion activity, number of relapses, immunogenicity, B-cell depletion, and safety.²

There were 118 individuals who had the SC formulation and 118 who had the IV formulation, with 89% and 89.8% having RMS and 9.3% and 10.2% having PPMS, respectively. The results showed that at 12 weeks, the geometric mean ratio of area under the concentration for SC compared with IV was 1.29, ranging from 1.23 to 1.35. The SC formulation also had near-complete suppression of MRI and relapse activity for up to 24 weeks, which was similar to the IV, according to the study authors. The SC formulation suppressed relapse activity at 97% and MRI lesions at 97%.^1,2

The safety profiles were also consistent, with no new concerns identified, according to the results. The most common adverse events included injection site reaction, with 49% of individuals experiencing it after first injection. All injection reactions were mild to moderate and did not lead to treatment discontinuation. Additionally, approximately 92% of patients in the trial were satisfied or very satisfied with the SC formulation.^1,2

“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. We are pleased that with a new method of delivery, there is now an additional option for those who need flexibility in the route of administration or treatment time.”¹

REFERENCES

1. FDA Approves Ocrevus Zunovo as the First and Only Twice-A-Year 10-Minute Subcutaneous Injection for People With Relapsing and Progressive Multiple Sclerosis. News release. Genentech. September 13, 2024. Accessed September 13, 2024. https://www.gene.com/media/press-releases/15036/2024-09-13/fda-approves-ocrevus-zunovo-as-the-first

2. Newsome S, Krzystanek E, Selmaj K, Goldstick L, et al. OCARINA II, Phase III Study: Results of Subcutaneous Ocrelizumab Administration in Patients with Multiple Sclerosis (S31.006). Neurology. 2024. doi:https://www.neurology.org/doi/10.1212/WNL.0000000000205244