U.S. FDA Accepts Biohaven's Supplemental New Drug Application (sNDA) Of NURTEC™ ODT For The Preventive Treatment Of Migraine

Biohaven Pharmaceutical Holding Company Ltd. | October 14, 2020

Biohaven Pharmaceutical Holding Company Ltd. today announced that the U.S. Food and Drug Administration (FDA) has filed and accepted for review its recently submitted supplemental New Drug Application (sNDA) for NURTEC™ ODT (rimegepant) for the preventive treatment of migraine. The Prescription Drug User Fee Act (PDUFA) goal date for completion of the FDA review of the preventive sNDA is set for 2Q2021. Vlad Coric, M.D., Chief Executive Officer of Biohaven commented, "Patients with migraine deserve the simplicity of managing their disease with a single medication that alleviates acute episodes and also works to prevent future attacks. Our goal with the NURTEC ODT development program has been to offer a fast acting, quick-dissolve oral tablet with "dual-acting" properties --acute and preventive-- to treat migraine across its full spectrum.  We believe that the ease of use associated with a single oral medication will benefit people with migraine so that they can take back their days, and also provides the health care system with a cost-effective approach as opposed to paying for two separate drugs for acute and preventive treatment."

Spotlight

To manage chronic medical conditions, real-time monitoring of disease-specific physiologic metrics is becoming an important part of standard of care, and smartphone technology is making it possible. Existing smartphone interfacing devices now record health parameters and metrics on diseases such as diabetes, cancer, respiratory diseases, heart failure, sleep disorders and more.

Spotlight

To manage chronic medical conditions, real-time monitoring of disease-specific physiologic metrics is becoming an important part of standard of care, and smartphone technology is making it possible. Existing smartphone interfacing devices now record health parameters and metrics on diseases such as diabetes, cancer, respiratory diseases, heart failure, sleep disorders and more.

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