On June 27, 2016, Genentech, a member of the Roche group, announced that the Biologics License Application (BLA) for ocrelizumab has been accepted for review by the United States Food and Drug Administration (FDA). This is the first time that an investigational medication is being reviewed for the treatment of two types of multiple sclerosis (MS): relapsing forms of MS (RMS) and primary-progressive MS (PPMS).
The FDA has also granted Priority Review Designation of the application, with a targeted action date of December 28, 2016. This means that the review of the application is expected to be completed by this date, as well as a decision on whether or not this investigational medication is approved. Genentech has submitted the brand name Ocrevus™ for use with ocrelizumab.
If approved, ocrelizumab would be the first medication available for both RMS and PPMS. Presently, 14 disease-modifying therapies are available for the treatment of relapsing forms of MS, but no treatments have been approved by the FDA for PPMS, which is a less-common form of the disease. PPMS is characterized by a steady accumulation of symptoms, versus sudden flare-ups and remissions.
http://mymsaa.org/news/fda-accepts-review-ocrelizumab/
The FDA has also granted Priority Review Designation of the application, with a targeted action date of December 28, 2016. This means that the review of the application is expected to be completed by this date, as well as a decision on whether or not this investigational medication is approved. Genentech has submitted the brand name Ocrevus™ for use with ocrelizumab.
If approved, ocrelizumab would be the first medication available for both RMS and PPMS. Presently, 14 disease-modifying therapies are available for the treatment of relapsing forms of MS, but no treatments have been approved by the FDA for PPMS, which is a less-common form of the disease. PPMS is characterized by a steady accumulation of symptoms, versus sudden flare-ups and remissions.
http://mymsaa.org/news/fda-accepts-review-ocrelizumab/