New MS treatment approved by FDA

The U.S. Food and Drug Administration (FDA) last week announced the approval of Zinbryta (daclizumab) for relapsing forms of multiple sclerosis (MS).

The treatment requires one self-administered injection per month.

“Zinbryta provides an additional choice to patients who may require a new option for treatment,” FDA Director of the Division of Neurology Products Dr. Billy Dunn said.

Two clinical trials of Zinbryta evaluated its effectiveness. Zinbryta and Avonex were compared in a 144 week study. The study had 1,841 participants. The Zinbryta participants had fewer relapses than the Avonex participants. The other trial compared Zinbryta to a placebo. Again, the participants who received Zinbryta in the year long trial fared better than those who received the placebo.

While Zinbryta is an important addition to treatments for MS, it also has serious safety risks. Only patients who have not responded to two or more current MS drugs should use Zinbryta. The medication will only be available through a restricted distribution program.

MS affects the central nervous system. The chronic, inflammatory condition is an autoimmune disease that is usually diagnosed between the ages of 20 and 40. The disease disrupts the communication between the brain and the body, resulting in decreased ability to function. Many patients suffer from a cycle of relapses and recovery periods. MS gradually reduces their ability to walk and participate in normal daily activities. There is no cure for MS.