Biohaven Achieves FDA Approval with Nurtec™
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).
In 2017, Biohaven was in need of clinical pharmacology and pharmacometrics expertise for Nurtec to supplement their drug development team. They engaged with Certara because of our proven experience in clinical pharmacology and pharmacometrics.
Certara was able to fill the gaps and worked closely alongside Biohaven’s scientists to use quantitative methods to advance Nurtec’s path to approval.
Migraine headaches are a debilitating neurological disorder that affects approximately 15% of the adult population in the United States (US), comprising approximately 38 million adults. Migraines rank as the third most prevalent disease worldwide and the seventh highest specific cause of disability worldwide.
