Ocrelizumab/hyaluronidase

Ocrelizumab/hyaluronidase
Combination of
OcrelizumabMonoclonal antibody
HyaluronidaseEndoglycosidase
Clinical data
Trade namesOcrevus Zunovo
AHFS/Drugs.comOcrevus-zunovo
License data
Routes of
administration
Subcutaneous
ATC code
  • None
Legal status
Legal status

Ocrelizumab/hyaluronidase, sold under the brand name Ocrevus Zunovo, is a fixed-dose combination medication used for the treatment of multiple sclerosis.[1] It contains ocrelizumab, a recombinant humanized monoclonal antibody directed at CD20;[1] and hyaluronidase (human recombinant), an endoglycosidase.[1] It is taken by subcutaneous injection.[1]

Ocrelizumab/hyaluronidase was approved for medical use in the United States in September 2024.[2][3]

Medical uses

Ocrelizumab/hyaluronidase is indicated for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease;[1] and primary progressive multiple sclerosis.[1]

References

  1. ^ a b c d e f g "Ocrevus Zunovo- ocrelizumab and hyaluronidase injection, solution". DailyMed. 25 September 2024. Retrieved 5 October 2024.
  2. ^ "FDA Approves Ocrevus Zunovo as the First and Only Twice-A-Year 10-Minute Subcutaneous Injection for People With Relapsing and Progressive Multiple Sclerosis". Genentech (Press release). 13 September 2024. Archived from the original on 14 September 2024. Retrieved 13 September 2024.
  3. ^ "Halozyme Announces FDA Approval of Roche's Subcutaneous Ocrevus Zunovo with Enhanze for People with Relapsing and Primary Progressive Multiple Sclerosis" (Press release). Halozyme Therapeutics. 13 September 2024. Archived from the original on 14 September 2024. Retrieved 13 September 2024 – via PR Newswire.
  • Clinical trial number NCT05232825 for "A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis (Ocarina II)" at ClinicalTrials.gov