The Foundation urged the agency to move quickly to make the drug available to patients. This action follows a recommendation last week by an independent advisory panel that the
The drug is already approved in Europe and Canada.
“AZLI is an
A letter to the FDA commissioner from Dr. Beall and Executive Vice President for Medical Affairs Preston W. Campbell, III, M.D., asks the FDA to expedite the approval process for the drug so that CF patients will have access to it as soon as possible.
Beth Sufian, a lawyer from Houston who has CF, testified before the advisory panel last week. “You have the power to change the lives of people with CF who struggle every day just to breathe,” she said.
AZLI was developed as a result of a therapeutics development award from the Cystic Fibrosis Foundation. If it receives FDA approval, it will be the first drug supported by such an award approved specifically for the treatment of cystic fibrosis.