OREANDA-NEWS. Roche announced today that the European Commission (EC) has granted marketing authorisation for OCREVUS® (ocrelizumab) for patients with active relapsing forms of multiple sclerosis defined by clinical or imaging features and for patients with early primary progressive multiple sclerosis in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity. Multiple sclerosis (MS) affects approximately 700,000 people in Europe, of which around 96,000 have the highly disabling primary progressive form. Most people with MS have a relapsing form (RMS) or primary progressive MS (PPMS) at diagnosis.

“For people in Europe living with MS, today’s approval of OCREVUS by the European Commission signifies an important advance in the treatment of their disease,’’ said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “OCREVUS is the first medicine to be approved for primary progressive MS, a debilitating form in which irreversible disability accumulates rapidly, and it provides a highly efficacious treatment option for people with relapsing forms of MS. We are committed to working with member states to provide access as quickly as possible to people with RMS and PPMS who may benefit from OCREVUS.”

“It is great news that OCREVUS, which has the potential to be a significant game changer in how we think about and treat MS, has been approved in the European Union today,” said Gavin Giovannoni, Professor of Neurology at Barts and The London School of Medicine and Dentistry, Queen Mary University of London. “Until OCREVUS, people with primary progressive MS, who often have to rely on a cane or wheelchair, give up work or have carers look after them, have not had an approved treatment to slow the progression of their disease. People with relapsing forms of MS often have to make difficult trade-off choices between safety and higher efficacy. OCREVUS is given every six months without the need for onerous monitoring, which we hope will allow people to live their lives without thinking about their treatment every day or every week.”

The EU approval is based on data from three pivotal Phase III studies from the ORCHESTRA trial programme of 2,388 patients who met primary and nearly all 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 with approximately 80 percent of patients relapse free and significantly slower 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 (NEDA; brain lesions, relapses and worsening of disability) by 64 percent in OPERA I and 89 percent in OPERA II compared with high-dose interferon beta-1a (p<0.0001 and p<0.0001).

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. Patients treated with OCREVUS were 24 percent less likely to have disability progression for three months and 25 percent less likely to have disability progression for six months (p=0.0321 and p=0.0365, respectively). OCREVUS also significantly slowed the progression of walking impairment by 29.4 percent, measured by the timed 25-foot walk, compared with placebo (p=0.0404).

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.

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. Over 30,000 people have been treated with OCREVUS to date.