ISSUE1714
- Mark Abramowicz, M.D., President has disclosed no relevant financial relationships.
- Jean-Marie Pflomm, Pharm.D., Editor in Chief has disclosed no relevant financial relationships.
- Discuss the potential advantages of Ocrevus Zunovo over the original formulation of ocrelizumab for treatment of multiple sclerosis.
Ocrevus Zunovo (Genentech), a subcutaneous (SC) formulation of the anti-CD20 monoclonal antibody ocrelizumab plus human recombinant hyaluronidase-ocsq has been approved by the FDA for treatment of primary progressive and relapsing forms of multiple sclerosis (MS). Intravenous ocrelizumab (Ocrevus), which was approved for the same indications in 2017, is one of the most commonly prescribed drugs for treatment of MS. Ocrelizumab remains the only drug approved for treatment of primary progressive MS.
A CLINICAL STUDY — Approval of the new formulation was based on preliminary results of an open-label noninferiority trial (OCARINA II) in 236 patients 18-65 years old with primary progressive or relapsing MS.1 At 12 weeks, the serum AUC (area under the concentration-time curve) of ocrelizumab following SC administration of ocrelizumab 920 mg was noninferior to that with IV administration of ocrelizumab 600 mg. Near-complete suppression of MRI lesion and relapse activity up to week 24 was achieved with both formulations and adverse effects were similar.
DOSAGE, ADMINISTRATION, AND COST — IV ocrelizumab is infused over at least 2 hours. The new formulation is injected subcutaneously in the abdomen over 10 minutes. Both IV and SC ocrelizumab are given every 6 months by a healthcare professional. Premedication with a corticosteroid and an antihistamine before each dose is recommended to reduce the risk of local and systemic reactions. The wholesale acquisition cost for one year’s treatment with Ocrevus or Ocrevus Zunovo is $78,858.2
CONCLUSION — Subcutaneous Ocrevus Zunovo offers a shorter and more convenient method of administration than intravenous ocrelizumab at the same cost.
- S Newsome et al. OCARINA II, phase III study: results of subcutaneous ocrelizumab administration in patients with multiple sclerosis. Neurology 2024; 102 (17_supplement_1). doi:10.1212/WNL.0000000000205244
- Approximate WAC. WAC = wholesaler acquisition cost or manufacturer’s published price to wholesalers; WAC represents a published catalogue or list price and may not represent an actual transactional price. Source: AnalySource® Monthly. October 5, 2024. Reprinted with permission by First Databank, Inc. All rights reserved. ©2024. www.fdbhealth.com/policies/drug-pricing-policy.