Biohaven and Pfizer Announce Positive Topline Results of Pivotal Trial of Rimegepant for the Acute Treatment of Migraine in China and South Korea
Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) and Pfizer Inc. (NYSE: PFE), today announced positive top-line results from an Asia-Pacific, Phase 3 clinical trial of rimegepant in 1,431 adults for the acute treatment of migraine. Led by BioShin Limited, a subsidiary of Biohaven in China and South Korea, the randomized, regional, multi-center study met the co-primary endpoints evaluating the efficacy and safety of the orally dissolving tablet (ODT) formulation of rimegepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist.
This is the fourth positive Phase 3 study of rimegepant for the acute treatment of migraine and the first to be conducted in Asia Pacific. The study met its co-primary endpoints of freedom from pain (p<0.0001) and freedom from most bothersome migraine–associated symptom (MBS) including either nausea, phonophobia or photophobia (p<0.0001) at 2-hours following a single oral dose of rimegepant. In the study, a single oral dose of rimegepant 75 mg provided significant relief of migraine symptoms and return to normal function at 2 hours and delivered sustained efficacy that lasted up to 48 hours for many patients. Rimegepant showed a favorable safety and tolerability profile among study participants that was consistent with prior clinical trial results in the United States. Detailed data from the study will be presented at future medical meetings to help inform ongoing and future research.
Under the terms of the collaboration agreement between Biohaven and Pfizer, Pfizer has commercialization rights to rimegepant in markets outside of the U.S. Biohaven continues to lead research and development globally and retains the U.S. market. Rimegepant is commercialized as Nurtec® ODT in the U.S. and is the only oral CGRP receptor antagonist approved for both the acute and preventive treatment of migraine in adults. An application for the approval of rimegepant is currently under review by the European Medicines Agency with a decision expected in the first half of 2022. Rimegepant is approved for the acute treatment of migraine in Kuwait and the United Arab Emirates, and for the acute and preventive treatment of migraine in Israel.
Vlad Coric, M.D., Chief Executive Officer and Chairman of the Board of Biohaven commented, “These top-line trial results clearly show the consistent clinical profile of rimegepant to relieve migraine symptoms and return patients to normal function. Through our partnership with Pfizer, we are committed to rapidly expanding the availability of rimegepant to patients around the world, particularly in Asia Pacific where migraine is a common disease and a leading cause of disability.”
“It is very exciting to see the completion and positive results of the first Phase 3 study of rimegepant in Asia Pacific,” said Nick Lagunowich, Global President, Pfizer Internal Medicine. “With millions of patients in the region impacted by this debilitating neurological disease, these results provide hope for a potentially new effective acute treatment for patients in need. We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with regulatory agencies around the world to do so.”
Professor Shengyuan Yu, Principal Investigator of the study and Director of the Department of Neurology, Chinese PLA General Hospital, said, “We need new, effective and safe treatment options to help improve the lives of our migraine patients in Asia and are encouraged by the positive results of this study.”
Donnie McGrath, M.D., Executive Chairman of Biohaven’s wholly-owned subsidiary in China, BioShin, added, “The results from this study demonstrate the effectiveness of rimegepant and highlight the potential impact for patients in Asia Pacific, if approved. I’m so proud of the BioShin R&D team who executed this study.”