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Novarro today announced the positive results of ASCLEPIOS I and II studies published in the New England Journal of Medicine(NEJM) that assessed the safety and effectiveness of monthly subcutral injections of of ofosamumab (OMB157) compared to oral fluoride (Telunifomide) once a day in adult patients with multiple sclerosis (RMS).
two studies reached the main endpoint, and the recurrence rate of patients in the ofatumumab group decreased significantly.
Ofatumumab (OMB157) is an all-human anti-CD20 monoclonal antibody (mAb) that can be given by monthly self-subsoccupal injection.
preclinical studies have shown that ofatumumab and CD20 molecules unique etosmology binding, induce B cell lysation and depletion.
: The ASCLEPIOS I and II studies recruited 1,882 MS patients aged 18-55, and the annual recurrence rate (ARR) in the Ofatumumab treatment group was significantly reduced by 51% (0.11 to 0.22) and 58% (0.10 to 0.25) in both studies.
Ofatumumab reduced the relative risk of disability exacerbation (CDW) by 34% (P s .002) in three months compared to Triflamin, and the relative risk of CDW by 32% (P s .01) in six months (secondary endpoint of the experiment).
Ofatumumab versus Teriflunomide in Multiple Sclerosis. N Engl J Med 2020;383:546-57. DOI: 10.1056/NEJMoa1917246 Stephen L. Hauser, Director of the Institute of Neuroscience at the University of California, San Francisco, said: "The ASCLEPIOS study found that ofatumab significantly reduces new inflammation and reduces clinical recurrence and progression events.
is a potentially new option for RMS patients, with 20,000 available compared to Triflamin, and patients need only inject themselves once a month, having the flexibility and convenience to do so.
February, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) accepted the company's application for a license (sBLA) and a market license (MAA) for the treatment of adult patients with recurrent multiple sclerosis.
approved, ofatumumab would be the first B-cell therapy that could be self-treated at home and could be the preferred treatment for RMS patients.
is expected to be approved in the United States in September 2020 and in Europe by the second quarter of 2021.
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