MS Speaks

More information about Ocrevus (ocrelizumab) is available in the "Doctor's Notes" section of the latest (Fall 2016) issue of MS Focus Magazine,  page 51. The article includes remarks by Dr. Ben Thrower:

FDA grants priority review for ocrelizumab

The U. S. Food and Drug Administration accepted for review Genentech's Biologics License Application for Ocrevus (ocrelizumab) for the treatment of relapsing and primary progressive multiple sclerosis, and granted the application Priority Review designation with a Dec. 28 targeted action date. If approved, Ocrevus would be the first and only treatment indicated for both forms of MS, which affect approximately 95 percent of people at diagnosis.

Priority Review designation 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.

[Dr. Ben Thrower, Senior Medical Adviser for MS Focus]:  More options for managing MS are always welcome. Zinbryta's (daclizumab) approval this summer introduces a treatment option with a unique mechanism of action. It would also seem to be convenient, with once monthly subcutaneous injections. As with any therapy, the benefits must be weighed against the risks. Zinbryta can be associated with serious liver damage and monthly lab testing is a must. In addition, mostly mild skin reactions can be seen. ... It's expected that Zinbryta will be mainly used as a second-line option when other therapies have not worked out.

Ocrevus (ocrelizumab) will likely be FDA-approved for both RMS and PPMS. As stated, this will be our first approved treatment option for PPMS. Ocrelizumab works similarly to rituximab. This drug has been used off-label for both MS and its cousin, neuromyelitis optica. The drug is given intravenously every six months and seems to be generally well-tolerated.  The infusion itself is slow, running about six hours on average.