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
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.
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.
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in
This press release contains forward-looking statements about liprotamase for the treatment of exocrine pancreatic insufficiency (EPI). It reflects Lilly's current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. There is no guarantee that liprotamase will be approved by the
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