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INDIANAPOLIS — The Food and Drug Administration declined to approve a drug made by Eli Lilly for treating a disease of the pancreas that often occurs in patients with cystic fibrosis, Lilly said.
The FDA issued a complete response letter to Lilly related to its application for liprotamase, a pancreatic enzyme replacement therapy for exocrine pancreatic insufficiency, requesting that the drug maker conduct an additional clinical trial before resubmitting its application. The FDA issues a complete response letter when it has finished reviewing the application for a drug, but issues remain that preclude final approval.
“Lilly is looking forward to further discussion with the FDA to address the items outlined in the letter and provide the requested information as quickly as possible,” Lilly VP autoimmune, bone-muscle-joint and liprotamase product development Eiry Roberts said. “We are committed to working with the agency and the cystic fibrosis community to make this important treatment available to patients.”