Ocrevus (ocrelizumab), a new drug to treat multiple sclerosis (MS), has been approved by the U.S. Food and Drug Administration (FDA). The National Multiple Sclerosis Society says it's a "game changer" and Dr. Dean Wingerchuk, a Mayo Clinic neurologist, says, "The approval of ocrelizumab is an important milestone — both for people with MS and MS research."
In a statement released on Wednesday, March 29, Dr. Billy Dunn, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research says, “This therapy not only provides another treatment option for those with relapsing MS, but, for the first time, provides an approved therapy for those with primary progressive MS.”
MS is a potentially disabling disease of the brain and spinal cord (central nervous system). In MS, the immune system attacks the protective sheath (myelin) that covers nerve fibers and causes communication problems between your brain and the rest of your body. Eventually, the disease can cause the nerves to deteriorate or become permanently damaged.
According to Dr. Wingerchuk there are an estimated 400,000 people in the U.S. who have MS, which means that roughly 1 in every 700 Americans have the disease. "It tends to strike people in early adulthood, so most people develop their first symptoms in their twenties or thirties, really when they’re in the primes of their lives." Dr. Wingerchuk is encouraged by the news about ocrelizumab:
"It is the first treatment shown to benefit primary progressive disease and will hopefully be a springboard to more effective drugs for treating this disabling type of MS. It also convincingly reduces activity and disability from relapsing MS, giving people with that form of the disease another powerful option. It is relatively safe but there are some important safety signals, including risks of cancer and infection, that will need close monitoring when the drug is used in usual practice." — Dr. Wingerchuk
Journalists: Broadcast-quality sound bites with Dr. Wingerchuk are in the downloads.
Dr. Wingerchuk concludes by saying, "I want to emphasize how much effort and how many resources are being poured into this disease, and for people and their families to know that we’ve got a lot of really brilliant people throughout the world who are doing their best to try to crack the mystery that’s MS and put a stop to it."
Mayo Clinic in Arizona participated in the ocrelizumab trial and received funds to support trial operations. Dr. Wingerchuk did not receive any personal compensation from the sponsor.