FDA Approves Ocrelizumab-Hyaluronidase-ocsq Combo for Relapsing or Primary Progressive MS

The FDA has approved the combination of ocrelizumab and hyaluronidase-ocsq for the treatment of relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, and primary progressive multiple sclerosis (PPMS), in adults.

The drug is administered as a subcutaneous injection.

Ocrelizumab is a CD20-directed cytolytic antibody initially approved in March 2017 for the treatment of patients with RMS or PPMS.

Hyaluronidase-ocsq (human recombinant) is an endoglycosidase used to increase the dispersion and absorption of coadministered drugs when administered subcutaneously.

The approval is based on a multicenter, randomized, open-label, parallel-arm trial (NCT05232825) that evaluated the comparative bioavailability, pharmacokinetics, pharmacodynamics, safety, and immunogenicity of the newly approved drug, compared with intravenous ocrelizumab in patients with either RMS or PPMS.

The study "enrolled 236 patients (213 with RMS, 23 with PPMS), 18-65 years of age with an EDSS between 0 to 6.5 at screening. The demographics were similar and baseline characteristics were balanced across the two treatment groups. The mean age was 40 years in both groups. In the [ocrelizumab-hyaluronidase-ocsq] group, 35% of patients were male and the mean/median duration since MS diagnosis was 5.7/3.1 years, compared to 41% male and 4.8/2.4 years in the ocrelizumab IV group," according to the prescribing information.

The differences in pharmacokinetic exposures following the administration of ocrelizumab and hyaluronidase-ocsq subcutaneously at 920 mg/23,000 units and ocrelizumab intravenously at 600 mg were not clinically significant.

The most common adverse reactions to the study drug were injection reactions.

Full prescribing information is here.

This combination medication is marketed by Genentech Inc. as Ocrevus Zunovo.