FDA Approves Rimegepant, Results on Ofatumumab Trial, Diazepam Becomes Commercially Available

March 7, 2020

Neurology News Network for the week ending March 7, 2020.

This week Neurology News Network covered the FDA approval of rimegepant, as well as results from the open-label APLIOS study of ofatumumab. Additionally, we discuss diazepam nasal spray and its commercial availability.

Marco: Welcome to Neurology News Network. I’m Marco Meglio. Let’s get into the news from this week.

The FDA has approved the use of 75-mg rimegepant in the acute treatment of migraine in adult patients, according to Biohaven, marking the company’s first agency approval of a product. Approval of the oral antagonist of the CGRP receptor was granted based on the results of 2 clinical trials: the phase 3 Study 303 and the long-term, open-label safety trial, Study 201. Rimegepant achieved statistical significance on the co-primary endpoints of pain freedom and freedom from the most bothersome symptom at 2 hours post-dose compared to placebo. Additionally, the treatment demonstrated statistical superiority at 1 hour for pain relief and return to normal function. Overall, rimegepant was generally well tolerated; the most common adverse event was nausea, which occurred in 2% of patients who received therapy compared to 0.4% of patients who received placebo.

Results of the open-label APLIOS study suggest that treatment with ofatumumab nearly completely depletes B cells over 12 weeks of treatment via an at-home autoinjector, which was found to be bioequivalent to a prefilled syringe of the multiple sclerosis treatment. The supplemental biologics license application for the novel, fully human antibody targeting CD20-positive B cells, was recently accepted by the FDA, who assigned a PDUFA date sometime in June 2020. In those trials, treatment with 20 mg ofatumumab once monthly resulted in over a 50% reduction in annualized relapse rate in ASCLEPIOS I and II, respectively, compared with treatment with teriflunomide. Stay with NeurologyLive for more coverage of ACTRIMS, including interviews with leaders in the field.

Neurelis has announced that diazepam nasal spray, a medication approved for the treatment of acute, intermittent, stereotypic episodes of frequent seizure activity, otherwise known as seizure clusters, is now commercially available for prescription. Chuck DeWildt, CEO of Neurelis, announced Maxor Specialty Pharmacy was selected as the national pharmacy provider and will continue to fill prescriptions going forth. Diazepam was originally approved in January 2020 for the treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in adult and pediatric patients 6 years of age and older. Neurelis also announced it will be offering a diazepam copay assistance program, where eligible patients can pay as low as $20 for the prescription. Additionally, the company has set up a patient assistance program designed to qualify those who don’t have insurance for additional assistance.

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