Related Content
- FDA approves Novartis drug for high blood pressure treatment
- FDA approves Merck's Gardasil for prevention of anal cancer
- New alliance will crack down on adulterated products touting dietary supplement claims
- Pfizer forms licensing agreement with Seattle Genetics
- Walgreens puts its money where its mouth is with World AIDS Day campaign
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.
