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news.The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Eli Lilly for its liprotamase new drug application (NDA) for the treatment of exocrine pancreatic insufficiency (EPI).
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Liprotamase is an oral, non-porcine (not made from harvesting the pancreas of pigs), biotechnology-derived, pancreatic enzyme replacement therapy (PERT) developed to treat patients with EPI associated with cystic fibrosis, chronic pancreatitis and pancreatectomy.
In the CRL, the FDA has aksed Eli Lilly to organize an additional clinical trial prior to a re-submission.
Lilly Liprotamase Product Development Autoimmune, Bone-Muscle-Joint, vice president Eiry Roberts said 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.
"We are committed to working with the agency and the cystic fibrosis community to make this important treatment option available to patients," Roberts said.