Roche’s OCREVUS (ocrelizumab) gains positive CHMP opinion for relapsing forms of multiple sclerosis and primary progressive multiple sclerosis

• If approved, OCREVUS will be an important treatment option for people with active relapsing forms of multiple sclerosis (RMS) showing superior efficacy on three major markers of disease activity and disability progression compared with Rebif (interferon beta-1a)
• If approved, OCREVUS will be the first and only medicine for people in the European Union (EU) with primary progressive multiple sclerosis (PPMS)

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Committee for Medicinal Products for Human Use (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.^1,2

"Today’s positive recommendation for OCREVUS is great news for people in Europe with active relapsing forms of MS as well as those with early primary progressive MS, who are all now one step closer to having this important new treatment option,’’ said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "We are pleased that the CHMP has recognised the clinical significance of the OCREVUS data, particularly for people living with primary progressive MS, a highly disabling disease that currently has no approved treatments in Europe.’’

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.

The most common side effects associated with OCREVUS in all Phase III studies were infusion reactions and upper respiratory tract infections, which were mostly mild to moderate in severity.

Based on this positive CHMP opinion, a final decision from the European Commission regarding the approval of OCREVUS is expected in the coming months. Following this decision, OCREVUS will then be granted marketing authorisation that will be valid in all 28 member states of the European Union.

OCREVUS has been approved for use in countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia and Switzerland. Approximately 20,000 patients have been treated with OCREVUS to date.