Roche has announced that the European Medicines Agency ( EMA ) has validated the company’s Marketing Authorisation Application ( MAA ) of Ocrevus ( Ocrelizumab ) for the treatment of relapsing multiple sclerosis ( RMS ) and primary progressive multiple sclerosis ( PPMS ) in the European Union ( EU ).
Validation confirms that the submission is complete and signifies the MAA is under review by the EMA’s Committee for Medicinal Products for Human Use ( CHMP ).
The U.S. Food and Drug Administration ( FDA ) has also accepted for review Roche’s Biologics License Application ( BLA ) for Ocrevus for the treatment of relapsing multiple sclerosis and primary progressive multiple sclerosis, and has granted the application Priority Review Designation with a targeted action date of 28 December 2016.
If approved by the EMA and FDA for both indications, Ocrevus would be the first and only treatment for both forms of multiple sclerosis, which affect approximately 95% of people at diagnosis.
The Ocrevus marketing applications are based on positive results from three phase III studies, which met primary and key secondary endpoints. Data from two identical studies ( OPERA I and OPERA II ) in people with relapsing multiple sclerosis showed superior efficacy of Ocrevus in reducing annualised relapse rates and disability progression sustained for at least three and for at least six months compared with Rebif ( Interferon beta-1a ).
Data from the ORATORIO study in people with primary progressive multiple sclerosis showed significant reductions in disability progression sustained for at least three and for at least six months, as well as in other measures of progressive disease compared with placebo.
Overall safety ( proportion of patients with adverse events and serious adverse events ) of Ocrevus in the phase III studies was similar to Interferon beta-1a in the RMS studies and to placebo in the PPMS study.
The most common adverse events associated with Ocrevus were infusion-related reactions and infections, which were mostly mild to moderate in severity.
Ocrelizumab is an investigational, humanised monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin ( nerve cell insulation and support ) and axonal ( nerve cell ) damage. This nerve cell damage can lead to disability in people with multiple sclerosis. Based on preclinical studies, Ocrelizumab binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, and therefore important functions of the immune system may be preserved. ( Xagena )
Source: Roche, 2016