重要な医薬品：Biohaven社の Nurtec™ 医薬品開発のジャーニー

A very effective migraine treatment involves inhibition of calcitonin gene-related peptide (CGRP) activity. Inhibition of CGRP decreases pain transmission, dilation of dural arteries, and blocks neurogenic inflammation, all of which contribute to migraine.

Migraine headaches are a debilitating neurological disorder affecting approximately 15% of the adult population in the US; that’s approximately 38 million adults. A migraine is a pulsating headache that can last from 4 to 72 hours. Sounds, smells, and routine physical activity are just some of the things that can trigger a migraine. Migraines rank as the third most prevalent disease worldwide and the seventh highest specific cause of disability worldwide.

In 2017, Biohaven needed clinical pharmacology and pharmacometrics expertise to supplement their in-house drug development team working on Nurtec™.

They called on Certara for that expertise. We began by performing a gap analysis to provide strategic direction and assess benefit/risk for the Rimegepant development program. More than 20 scientists and regulatory experts at Certara partnered with Biohaven scientists to advance NurtecTM’s path to approval.

Certara scientists provided expertise in clinical pharmacology, pharmacometrics, regulatory strategy, Physiologically Based Pharmacokinetic Model (PBPK) modeling, Medical Affairs and Scientific Communications Services and project management. These continued collaborative efforts led to FDA and EU approval of NurtecTM ODT for acute treatment and prevention of episodic migraine.

Biohaven also needed support to plan and execute their Phase 1 migraine publication plan. Certara’s Medical Affairs and Scientific Communication Services team supported this aspect of Nurtec™ development. We worked with Biohaven to build a publication plan that included recommended journals, iterative review processes, quality checks, and journal submission.

We helped to develop, publish and present high quality manuscripts, abstracts, and posters adhering to journal/target venue specifications, including Good Publication Practice (GPP 2022) and ICMJE guidelines. We provided written responses to reviewers as required and helped generate publication quality figures and graphics. As of July 2024, 9 manuscripts have been published along with 16 abstracts and posters to support this important work.

Approval of Nurtec™ by the European Medicines Agency used PBPK modeling using Simcyp that negated the need for a dedicated Phase I clinical pharmacology study. The modeling work showed that high gastric pH did not significantly affect Nurtec™ bioavailability with the ODT formulation. This modeling effort saved time and cost and helped to speed this pivotal migraine medication to patients.