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Eli Lilly Says FDA Advisory Committee Recommends Non-approval Of Liprotamase

Eli Lilly and Co. (LLY) Wednesday said the U.S. Food and Drug Administration Gastrointestinal Drugs Advisory Committee voted to recommend non-approval of liprotamase, a non-porcine pancreatic enzyme replacement therapy, currently under FDA review for the treatment of exocrine pancreatic insufficiency.

During the meeting, the committee had questions about the degree of efficacy of liprotamase and recommended that additional studies be conducted prior to considering approval of liprotamase for EPI.

Liprotamase is an oral, non-porcine, pancreatic enzyme replacement therapy (PERT) under FDA review for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and pancreatectomy.

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