FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

Ocrevus (ocrelizumab)

Indication:

Relapsing or primary progressive forms of multiple sclerosis (PPMS).

Mechanism:

Monoclonal antibody designed to selectively target CD20, a cell surface antigen present on pre-B and mature B lymphocytes.

Dosage:

Initial: 300 mg IV once, then repeat 2 weeks later

Maintenance: 600 mg IV every 6 months

Approval:

Approval was based on results from the ORATORIO phase 3 trial that included 732 patients with PPMS who received the treatment or matching placebo. Ocrelizumab was associated with lower rates of clinical and MRI progression than placebo. By week 120, performance on the timed 25-foot walk worsened by 38.9% with ocrelizumab versus 55.1% with placebo (P=0.04). The total volume of brain lesions on T2-weighted MRI decreased by 3.4% with ocrelizumab and increased by 7.4% with placebo (P<0.001), while the percentage of brain-volume loss was 0.90% with ocrelizumab versus 1.09% with placebo (P=0.02).

Reference:

Hauser SL, et al. Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med. 2017 Jan 19;376(3):221-34.

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