Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20 Page 21 Page 22 Page 23 Page 24 Page 25 Page 26 Page 27 Page 28 Page 29 Page 30 Page 31 Page 32 Page 33 Page 34 Page 35 Page 36 Page 37 Page 38 Page 39 Page 40 Page 41 Page 42 Page 43 Page 44 Page 45 Page 46 Page 47 Page 48 Page 49 Page 50 Page 51 Page 52 Page 53 Page 54 Page 55 Page 56 Page 57 Page 58 Page 59 Page 60 Page 61 Page 62 Page 63 Page 64 Page 65 Page 66 Page 67 Page 6851 msfocusmagazine.org Frustratingly, the person with longstanding disability, i.e. in a wheelchair for years, may be the person least likely to benefit from stem cell treatment. FDA approves Zinbryta for use in treatment The U.S. Food and Drug Administration approved Zinbryta™ (daclizumab) for the treatment of adults with relapsing forms of multiple sclerosis. Zinbryta is a long-acting injection that is self-administered by the patient monthly. The effectiveness of Zinbryta was shown in two clinical trials. Biogen and AbbVie plan to make Zinbryta available in the third quarter of 2016. FDA grants priority review for ocrelizumab The U.S. Food and Drug Administration accepted for reviewGenentech’sBiologics 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. Thrower – 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. Peo- ple on Zinbryta need to let their healthcare team know if they are experiencing any new rashes. 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. Ocre- lizumab works similarly to rituximab. This drug has been used off-label for both MS and its cousin, neu- romyelitis optica. The drug is given intravenously every six months and seems to be generally well-tolerated. The in- fusion itself is slow, running about six hours on average. Frustratingly, the person withlongstandingdisability, i.e.inawheelchairforyears, may be the person least likely to benefit from stem cell treatment.