Innovative Drug Development: Kalydeco Provides A Paradigm, FDA’s Spielberg Says

The deputy commissioner detailed the steps involved in getting Vertex’s cystic fibrosis drug rapidly through the approval process and noted that FDA is working on innovative study designs and assessing how to better use diagnostics.

The development of Vertex Pharmaceuticals Inc.’s cystic fibrosis therapy Kalydeco (ivacaftor, VX-770) is a model for how to efficiently and effectively get a drug through the approval process, Stephen Spielberg, FDA’s Deputy Commissioner for Medical Products & Tobacco, told the Biotechnology Industry Organization’s CEO & Investor Conference in New York Feb. 14.

“It’s a paradigm for how things can work if done right,” Spielberg said.