In the third installment of a podcast series, “Real-World Evidence — Is it a Game Changer for the FDA?”, Avalere Health Regulatory Science and Commercial Strategy Vice President Brenda Huneycutt and Ernest Voyard, director, spotlight real-world evidence in product development.
Huneycutt and Voyard point to a new commitment by drugmaker Vertex, which is taking on a 3-year study of patients registered in the U.S. Cystic Fibrosis Foundation Patient Registry who have been reported as having a newly-designated CFTR gene mutation with indications Kalydeco is having an impact.
“This study will evaluate select patient outcomes, including lung function, and select cystic fibrosis complications,” Voyard says. “When completed, the study will meet the post-marketing commitment.”
