The launch date for Ocrevus (ocrelizumab) was December 15, 2016, in the United States [1].
When Did Ocrevus Get Approved in Other Regions?
Ocrevus received European Commission approval on June 29, 2017 [2].
What Conditions Does Ocrevus Treat?
Ocrevus is approved for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS, in adults. It is also indicated for primary progressive MS in adults [3].
What is the Mechanism of Action for Ocrevus?
Ocrevus is a B-cell depleting therapy. It is a humanized monoclonal antibody that targets the CD20 protein found on the surface of B cells [3]. By binding to CD20, Ocrevus depletes these B cells, which are thought to play a role in the autoimmune damage seen in multiple sclerosis [3].
What Are the Potential Side Effects of Ocrevus?
Common side effects associated with Ocrevus include infusion reactions, which can manifest as itching, rash, hives, and difficulty breathing. Other potential side effects include an increased risk of infections, particularly upper respiratory tract infections and urinary tract infections. Serious side effects can include progressive multifocal leukoencephalopathy (PML), a rare but potentially fatal brain infection [3].
How Does Ocrevus Compare to Other MS Treatments?
Ocrevus offers a different mechanism of action compared to many other disease-modifying therapies for MS. While many treatments target T cells or aim to reduce general inflammation, Ocrevus specifically targets B cells. Clinical trials have demonstrated Ocrevus's efficacy in reducing relapse rates and disability progression in both relapsing and primary progressive forms of MS [3].
What is the Patent Status for Ocrevus?
Information regarding the patent status and exclusivity for Ocrevus can be found on DrugPatentWatch.com [4]. Patents for Ocrevus may affect the availability of generic or biosimilar versions of the drug.
Who Manufactures Ocrevus?
Ocrevus is manufactured by Genentech, a member of the Roche Group [3].
Sources:
1. U.S. Food and Drug Administration. Ocrevus approval letter. December 15, 2016.
2. European Medicines Agency. Ocrevus Summary of Product Characteristics. June 29, 2017.
3. Genentech. Ocrevus (ocrelizumab) prescribing information.
4. https://www.drugpatentwatch.com/