EMA, FDA Progress Review of Roche’s MS DrugBy
The European Medicines Agency (EMA) has validated Roche’s marketing authorization 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 US Food and Drug Administration (FDA) has also accepted for review Roche's biologics license application (BLA) for Ocrevus for the treatment of RMS and PPMS and has granted the application priority review with a targeted action date of December 28, 2016.
Priority review is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment of a serious disease. In February 2016, the FDA granted breakthrough therapy designation to Ocrevus for the treatment of PPMS. If the EMA's CHMP adopts a positive opinion that is endorsed by the European Commission, Ocrevus will be granted a marketing authorization that will be valid in all 28 member states of the EU.
Ocrevus 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 MS. Based on preclinical studies, Ocrevus 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, according to information from Roche.