At long last, and for the first time in medical history, people with both relapsing and primary progressive forms of multiple sclerosis have reason to celebrate. The U.S. Food and Drug Administration (FDA) today approved Ocrevus (ocrelizumab) as a disease-modifying therapy for both forms of MS, a chronic autoimmune disease.
The FDA’s decision is historic for primary progressive (PPMS) patients, who until now had no accepted means of slowing the relentless march of their illness, and it’s historic for relapsing MS patients — studies showed that Ocrevus effectively halted the disease in nearly half of treated RMS patients.
It’s also historic for the future of MS research and treatment. Ocrevus defied all norms by targeting immune system B-cells and, in clinical studies, surpassed most expectations to become what may be the most powerful drug yet developed against MS.
“The FDA’s approval of OCREVUS is the beginning of a new era for the MS community and represents a significant scientific advance with this first-in-class B-cell targeted therapy,” Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech, said in a late-breaking press release.
European health authorities are also reviewing Genentech’s request for EU approval (called a marketing application), and decisions in other countries are likely to follow.
“This is an exciting day for everyone touched by MS, a disease that strikes in the prime of a person’s life when she or he may be starting a career or family. For many people living with MS, this FDA approval is a source of hope,” said June Halper, chief executive officer at the Consortium for MS Centers, said in the release.
“[I]f everything works out, it looks as if Ocrevus, although not a cure, has all the makings of a wonder drug for MS, at least for most people who have the disease,” Ian Franks, chief columns editor for BioNews Services, the parent company of Multiple Sclerosis News Today, wrote earlier this month, adding that the March 28 choice of approval date was “quite poetic really, in that it is MS Awareness Month.”
Upon learning of the FDA’s action, Franks said: “While there are other DMTs [disease-modifying therapies] for relapsing MS, I find it tremendously encouraging that Ocrevus has been approved for treating primary progressive. Looking to the future, perhaps we might not be so far away from developing treatment specifically for secondary progressive.” Franks, who was diagnosed with multiple sclerosis in April 2002, has non-relapsing SPMS.
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