Agreement on an iPSP is one of the regulatory requirements that must be met prior to submitting a NDA.
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| [20-November-2017] |
| NEW HAVEN, Conn., Nov. 20, 2017 /PRNewswire/ -- Biohaven announced today that the Company has received agreement from the U.S. Food and Drug Administration (FDA) on the initial pediatric study plan (iPSP) for orally-dosed rimegepant. Rimegepant is a second-generation, small molecule, calcitonin gene-related peptide (CGRP) receptor antagonist being developed for the acute treatment of migraine. Agreement on an iPSP is one of the regulatory requirements that must be met prior to submitting a new drug application (NDA). “We are pleased to have the FDA’s agreement on an iPSP, which marks another key milestone in our CGRP development program,” said Vlad Coric, M.D., Chief Executive Officer of Biohaven. “Millions of Americans who suffer from migraine are not being helped by the current approved therapies, and we believe rimegepant has the potential to provide them with a safe and effective migraine treatment with the ease of oral dosing. We are now another step closer toward preparing our regulatory package and eagerly await topline data from our two Phase 3 trials in the first quarter of 2018.” Biohaven recently reported completion of enrollment in the first of the Company’s two pivotal Phase 3 studies evaluating the efficacy and safety of rimegepant in the acute treatment of migraine. Patients who have participated in the Phase 3 clinical trials are eligible to participate in an ongoing long-term safety study. In addition to rimegepant, Biohaven is also pursuing the development of its third generation CGRP-receptor antagonist, BHV-3500, for acute and preventative treatment for migraine. “Our regulatory team has been working since May of 2017 to gain alignment with the FDA on the iPSP, and we are very pleased to have now accomplished this important step toward an NDA filing. Our development program for rimegepant is designed to demonstrate comprehensive and durable treatment benefits and a favorable safety profile for migraine sufferers,” said Marianne Frost, Head of Regulatory Affairs at Biohaven. About Migraine Migraine is both a widespread and disabling neurological disease. The Migraine Research Foundation ranks migraine as the world’s third most prevalent illness, affecting approximately 36 million people in the United States. Current treatment approaches, such as triptans, can be limited by headache recurrence within 24 hours after taking migraine medication, as well as cardiovascular contraindications and warnings. About Biohaven Biohaven is a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, including rare disorders. Biohaven has combined internal development and research with intellectual property licensed from companies and institutions including Bristol-Myers Squibb Company, AstraZeneca AB, Yale University, Catalent, Rutgers, ALS Biopharma LLC and Massachusetts General Hospital. Currently, Biohaven’s lead development programs include multiple compounds across its CGRP receptor antagonist and glutamate modulation platforms. The company’s common shares are listed on the New York Stock Exchange and traded under the ticker symbol BHVN. More information about Biohaven is available at www.biohavenpharma.com. Rimegepant is one of only two small molecule CGRP-receptor antagonists in late stage clinical development. Forward-Looking Statements This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Company’s management. All statements, other than statements of historical facts, included in this press release, including the Company’s timing of the expected data readouts from the Company’s registrational trials of rimegepant, the potential for rimegepant to provide a safe and effective treatment option for the acute treatment of migraine, are forward-looking statements. The use of certain words, including the “believe” and “will” and similar expressions are intended to identify forward-looking statements. The Company may not actually achieve the plans and objectives disclosed in the forward-looking statements and you should not place undue reliance on the Company’s forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements, including uncertainties relating to the future clinical success of rimegepant, and whether the results observed in the Phase 2b clinical trial will be observed in the Phase 3 pivotal trials. Additional important factors to be considered in connection with forward-looking statements are described in the “Risk Factors” section of the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 14, 2017. The forward-looking statements are made as of this date and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. For further information, contact Dr. Vlad Coric, the Chief Executive Officer at Vlad.Coric@biohavenpharma.com View original content with multimedia:http://www.prnewswire.com/news-releases/biohaven-receives-agreement-from-fda-on-initial-pediatric-study-plan-for-rimegepant-a-second-generation-oral-cgrp-receptor-antagonist-for-the-acute-treatment-of-migraine-300559168.html SOURCE Biohaven Pharmaceutical Holding Company Ltd. | ||
Company Codes: NYSE:BHVN |
