10 November 2017 - If approved, Ocrevus will be the first and only medicine for people in the European Union (EU) with primary progressive multiple sclerosis.

Roche announced today that the CHMP has adopted a positive opinion for the use of Ocrevus for people with active relapsing forms of multiple sclerosis defined by clinical or imaging features and for people with early primary progressive multiple sclerosis in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity. In Europe, multiple sclerosis (MS) affects approximately 700,000 people and the majority have a relapsing form of MS or primary progressive MS at diagnosis.

The positive CHMP opinion is based on data from three pivotal Phase III studies, which met primary and key secondary endpoints. Data from two identical Phase III studies in relapsing forms of MS (OPERA I and OPERA II) showed Ocrevus demonstrated superior efficacy on reducing the number of attacks (relapses) per year by nearly half and significantly slowed progression of the disease compared with high-dose interferon beta-1a (Rebif) over the two-year controlled treatment period. Ocrevus also significantly increased the chance of a patient having no evidence of disease activity (brain lesions, relapses and worsening of disability).

In a separate PPMS Phase III study (ORATORIO), Ocrevus was the first and only treatment to significantly slow disability progression and reduce signs of disease activity in the brain (MRI lesions) compared with placebo with a median follow-up of three years.

Read Roche press release