Eli Lilly receives FDA complete response letter for liprotamase NDA

Eli Lilly and Company (NYSE: LLY) 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 (EPI).

The complete response letter communicated the need for Lilly to conduct an additional clinical trial prior to a re-submission.

"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," said Eiry Roberts, M.D., Vice President, Autoimmune, Bone-Muscle-Joint, Liprotamase Product Development at Lilly.  "We are committed to working with the Agency and the cystic fibrosis community to make this important treatment option available to patients."

People with EPI have very low levels or none of the key digestive enzymes made by the pancreas - lipase, amylase and protease - in their small intestine, resulting in improper digestion and absorption of fat, carbohydrates and proteins, often requiring treatment with PERTs. EPI occurs very frequently in patients with cystic fibrosis (a life-threatening genetic disorder) and in other diseases including chronic pancreatitis and pancreatectomy.