Biohaven 的 Nurtec™ 获得美国食品药品监督管理局 (FDA) 批准
In February 2020, Biohaven announced that the U.S. Food and Drug Administration (FDA) approved Nurtec™ ODT (rimegepant) for the acute treatment of migraines in adults.
It is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting, orally disintegrating tablet (ODT).
Certara’s contribution to the drug development program for Nurtec ODT was substantial. Their clinical pharmacology representative worked seamlessly with the Biohaven Development Team. Certara’s considerable expertise in clinical pharmacology and pharmacometrics and flawless execution supported Nurtec’s clinical development team and helped to prepare the clinical pharmacology NDA components.