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An experimental drug showed positive results in three phase 3 trials for multiple sclerosis, according to new research published Thursday in the New England Journal of Medicine.
Phase 3 trials test the efficacy and safety of a new drug in human patients.
In one phase 3 trial, patients with primary progressive MS who were given the experimental drug ocrelizumab had less medical evidence and brain scan evidence of disease progress compared to patients given a placebo.
And in two other, separate phase 3 trials, patients with relapsing forms of MS who were given ocrelizumab showed lower rates of disease activity and progression compared to patients receiving Interferon beta 1a, a standard MS treatment.
The researchers caution that extended observation is required to determine the long-term safety and efficacy of the drug.
Ocrelizumab (Ocrevus) is under review by the Food and Drug Administration for approval for both primary progressive and relapsing MS. For the primary progressive multiple sclerosis indication, the FDA has given Breakthrough Designation and priority review, in order to move up the time line for potential approval.
The FDA does not comment on drugs that are under review. Still, the reason for an expedited approval process seems obvious. It is needed.
"No treatments have been approved by the FDA for primary progressive MS," said Dr. Jack Burks, chief medical consultant for the Multiple Sclerosis Association of America. He said only about 10% of the MS population is estimated to be diagnosed with the primary progressive form of MS, but "this still represents tens of thousands of individuals who currently have no available treatment options."
How it works
Ocrelizumab selectively targets CD20-positive B cells, a type of immune cell. B cells are thought to be a key contributor to myelin (nerve cell insulation) and nerve cell damage, which can result in disability for patients with MS, said Peter Chin, group medical director for neuroscience at Genentech, the company that makes the drug.
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