FDA Approves Roche’s Ocrevus for Relapsing and Primary Progressive MS
Roche won FDA approval for its Ocrevus (ocrelizumab) treatment for relapsing and primary progressive forms of multiple sclerosis.
According to clinical trial results in two Phase III studies, Ocrevus demonstrated superior efficacy on the three major markers of disease activity by reducing relapses per year by nearly half, slowing the worsening of disability and significantly reducing MRI lesions compared with Rebif (high-dose interferon beta-1a) over the two-year treatment period. Rates of serious adverse events and infections were similar between the two arms.
In a separate Phase III study in primary progressive MS, Ocrevus significantly slowed disability progression and reduced signs of disease activity in the brain compared to placebo after a median follow-up of three years.
Ocrevus is currently under review by the European Medicines Agency.