FDA Grants 2 Designations for Cystic Fibrosis Treatments
Colorado U.S. Senator Michael Bennet released the following statement after Vertex Pharmaceuticals announced two of its cystic fibrosis treatments were granted the first Breakthrough Therapy Designations from the U.S. Food and Drug Administration (FDA). The new breakthrough designations are the result of a provision Bennet passed in the FDA reform bill last year and is intended to bring lifesaving drugs and treatments to patients more quickly and safely.
“These breakthrough designations are welcomed news for patients who live their daily lives suffering from cystic fibrosis and are waiting to learn if potential new treatments can help them,” Bennet said. “Now, FDA will work with Vertex to move these potentially lifesaving treatments through the FDA’s approval process quickly and safely – and hopefully they’ll be in the hands of patients in the near future. Our goal for the breakthrough designation is that it will help bring more and more lifesaving cures to patients more efficiently than ever before.”
Last year, Bennet worked with Senators Orrin Hatch (R-UT) and Richard Burr (R-NC) to include the breakthrough provision in the FDA Safety and Innovation Act of 2012 to expedite FDA approval and provide more flexibility for breakthrough drugs or treatments that show dramatic responses early in development, while still ensuring drug safety and efficacy.