The Food and Drug Administration (FDA) has approved Ocrevus (ocrelizumab injection; Genentech) for the treatment of patients with relapsing or primary progressive forms of multiple sclerosis (MS). This is the first drug approved by the FDA to treat primary progressive MS. According to the Centers for Disease Control and Prevention, approximately 15% of patients with MS have the primary progressive form.
The approval was based on results from three Phase 3 clinical trials: OPERA I and OPERA II which included patients with relapsing MS (n=1656) and ORATORIO which involved patients with primary progressive MS (n=732). In the relapsing MS studies, both trials compared Ocrevus to interferon beta 1a (Rebif; EMD Serono). After 96 weeks of treatment, patients on Ocrevus demonstrated reduced relapse rates and reduced worsening of disability compared to those on comparator drug. In the primary progressive trial, treatment with Ocrevus significantly slowed disability progression and reduced signs of disease activity in the brain (MRI lesions) compared to placebo; median follow-up was three years.
The most common adverse reactions in patients with relapsing MS receiving Ocrevus were upper respiratory tract infections and infusion reactions. In addition, patients with primary progressive MS experienced skin infections, and lower respiratory tract infections.
Ocrevus is a humanized monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin and axonal damage. The exact mechanism by which ocrelizumab exerts its therapeutic effect in MS is unknown, however it is thought to involve binding to CD20, a cell surface antigen present on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, ocrelizumab results in antibody-dependent cellular cytolysis and complement-mediated lysis.
Ocrevus is contraindicated in patients with active hepatitis B virus infection. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with other anti-CD20 antibodies. Screening for HBV should be performed before starting treatment.
Ocrevus will be available within the next two weeks and is supplied as a 300mg/10mL single-dose vial. It is administered by intravenous infusion by a healthcare professional with the first two doses given two weeks apart and subsequent doses every 6 months. Patients should be monitored closely during and for at least one hour after infusion.
For more information call (844) 627-3887 or visit Ocrevus.com.