Ocrelizumab achieves primary endpoints treating primary progressive multiple sclerosis.
Researchers have long been analyzing the potential multiple sclerosis (MS) drug ocrelizumab (Ocrevus/Genetech). Results from phase 3 trials were been published in the New England Journal of Medicine (NEJM) on December 21, 2016.
The NEJM published 2 reports including 3 studies on the drug—one assessing outcomes on relapsing MS (RMS) and the other on primary progressive MS (PPMS).
“The primary endpoint was met in all 3 studies, which includes relative reduction of annualized relapse rate in the RMS studies and relative reduction in the progression of clinical disability sustained for at least 12 weeks in the PPMS study,” according to a company news release.
Findings from the OPERA I and II trials on ocrelizumab were presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS 2015) in Barcelona, Spain. While the outcomes were positive, study author, Stephen L. Hauser, MD, from the University of California, said that the results were incomplete for results on new and enlarged T2 lesions.
At the following ECTRIMS 2016 meeting in London, United Kingdom, results were positive again. However, the data revealed that Short Form-36 (SF-36) outcomes, which measures function health within 8 concepts, did not differ between participants who took ocrelizumab or placebo.
Ocrelizumab is currently being reviewed by the FDA and a decision is expected on March 28, 2017.
The NEJM reports are “Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis” and “Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis.”