Biohaven’s agent is now the first oral CGRP antagonist to be approved for prevention, and the first to be approved for both acute and preventive therapy. It is marketed as Nurtec ODT and is administered in a 75-mg dose.
The FDA has approved 75-mg rimegepant (Nurtec ODT; Biohaven) for the preventive treatment of migraine, Biohaven has announced, adding to its prior indication for the acute treatment of the headache disorder, and marking it as the first oral calcitonin gene-related peptide (CGRP) antagonist to be approved for prevention and the first to be approved for both acute and preventive therapy.1
The orally disintegrating anti-CGRP tablet was originally approved in a 75-mg dose for the acute treatment of migraine in February 2020—the first approval of a therapy for Biohaven.2 The application for the preventive indication was accepted for review by the agency in October 2020.
"The FDA approval of Nurtec ODT for the preventive treatment of migraine—along with its acute treatment indication—is one of the most groundbreaking things to happen to migraine treatment in my 40 years of practicing headache medicine,” Peter J. Goadsby, MD, PhD, DSc, professor of neurology, University of California, Los Angeles, and King's College London, and co-author of the phase 3 preventive study, said in a statement.1 “To have one medication patients can use to treat and prevent migraine will likely change the treatment paradigm for many of the millions of people who live with migraine."
The decision was made based on supporting data included in the supplement new drug application (sNDA) from the pivotal phase 3 clinical trial, known as Study 305. Those data showed that the CGRP therapy decreased monthly migraine days by 4.3 day per month at month 3, compared to the placebo group’s 3.5-day reduction (difference, 0.8; P <.05). Additionally, of those in the rimegepant group, 49.1% reported at least a 50% reduction from the baseline number of moderate to severe migraine days compared to 41.5% in the placebo group (P <.05).1,3
In January 2021, Richard B. Lipton, MD, professor and vice-chair of neurology, Albert Einstein College of Medicine, and director, Montefiore Headache Center, and a co-investigator in the clinical development of rimegepant, spoke with NeurologyLive about the potential of having a single therapy for both prevention and on-demand migraine treatment. “Instead of saying to a patient, ‘you need an acute treatment, you need a preventive treatment; here are 2 drugs for your problem’, I can say, ‘here's 1 drug for your problem, you can take it every other day if you have frequent headaches, and that'll cut down your headache frequency,’” he told NeurologyLive. You can watch more of what he had to say about the drug in the video below.
Additionally, the sNDA was supported by data from the long-term, open-label safety study, Study 201, which was included in the original NDA for rimegepant’s acute treatment indication. That study included 1800 participants who used the agent once per day, including 1131 individuals who were exposed to the drug for at least 1 year. Every patient included in the 1-year data treated a mean of 2 migraine attacks per month.
Overall, rimegepant was generally well-tolerated in Study 305, with the most common adverse events (AEs) being nausea (2.7% vs 0.8% in placebo) and stomach pain/indigestion (2.4% vs. 0.8% in placebo). The therapy is contraindicated in patients with a history of hypersensitivity to rimegepant, or to any of its components.
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"This FDA approval marks the beginning of a new era for migraine treatments, allowing the potential for healthcare professionals to prescribe, and patients to have, a single medication to treat and prevent migraine attacks,” Vlad Coric, MD, chief executive officer, Biohaven, said in a statement.1 “Nurtec ODT is dissolving the line between acute and preventive treatment. This groundbreaking approach to treating the full spectrum of migraine disease, from acute therapy to prevention, can have a significant impact in a patient's life by helping to decrease treatment plan complexity and reduce challenges with adherence and polypharmacy.”
Recently, in April 2021, data presented by Kathleen B Mullin, MD, medical director, clinical research, New England Institute for Clinical Research, at the 2021 American Academy of Neurology (AAN) Annual Meeting, from a long-term, open-label safety study (NCT03266588) of adults with migraine and a history of triptan treatment failure revealed that long-term treatment with rimegepant is safe and well-tolerated up to once daily.4
A total of 1800 individuals with 4 to 14 severe monthly migraine attacks were assigned to scheduled dosing of rimegepant 75 mg every other day for 12 weeks supplemented by as-needed dosing on nonscheduled dosing days. Of those, 546 (30.3%) had a history of treatment failure with 1 triptan and 246 (13.7%) had failed 2 or more triptans. Upper respiratory tract infection (1 triptan: 9.5%; ≥2 triptans: 8.9%), nasopharyngitis (1 triptan: 7.9%; ≥2 triptans: 8.1%) and sinusitis (1 triptan: 4.6%; ≥2 triptans: 8.1) were among the most common AEs observed. In total, 1.6% and 2.0% of patients who had a history of treatment failure with 1 or 2 or more triptans discontinued rimegepant treatment due to AEs, respectively. Serious AEs occurred in 3.7% of subjects who had a history with 1 triptan failure, compared to 2.4% of those with at least 2 or more. None of these were considered to be related to treatment with rimegepant.4