Case Study: Biohaven Pharmaceuticals accelerates Nurtec approval and migraine care with Certara clinical pharmacology and PBPK modeling

Medicines that matter Biohaven’s Nurtec™ drug development journey

Biohaven Pharmaceuticals, a biotech company, required clinical pharmacology and pharmacometrics expertise to support the development of their migraine drug, Nurtec™. They engaged vendor Certara to supplement their in-house team and provide strategic direction for the drug development program.

Certara provided a comprehensive solution, including clinical pharmacology, pharmacometrics, regulatory strategy, and PBPK modeling using their Simcyp™ Simulator. This effort, which included supporting the publication of numerous manuscripts and abstracts, led to the FDA and EU approval of Nurtec™ for both acute and preventive migraine treatment. A key result was the use of PBPK modeling to negate the need for a dedicated clinical study, saving significant time and cost. The ultimate impact is a highly effective treatment that has greatly improved the quality of life for patients like veteran Gregory Peterman.

Biohaven Pharmaceuticals

Richard Bertz

Senior Vice President, Clinical Pharmacology & Pharmacometrics