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.”
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.
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.