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INDIANAPOLIS — An advisory committee of the Food and Drug Administration voted last week not to recommend approval of a drug from Eli Lilly.
The FDA Gastrointestinal Drugs Advisory Committee said it recommended that additional studies be conducted prior to the FDA's review of liprotamase, a nonporcine pancreatic enzyme replacement therapy, for the treatment of exocrine pancreatic insufficiency. EPI is a disease resulting from cystic fibrosis, removal of the pancreas, chronic pancreatitis and other conditions.
Lilly's PERT was developed by Alnara, which the drug maker acquired in July 2010.
The FDA is not required to follow the recommendation of its advisory committees.