FDA Issues Response Letter for Liprotamase

April 19, 2011

Eli Lilly and Company has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for liprotamase, a non-porcine pancreatic enzyme replacement therapy (PERT), under investigation for the treatment of exocrine pancreatic insufficiency.
 
The complete response letter communicated the need for Lilly to conduct an additional clinical trial prior to a re-submission.
 
The CF Foundation will continue to work with Eli Lilly and the FDA as liprotamase moves through the FDA review and approval process.
 
Read more in the news release from Eli Lilly.