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Statement From Lilly on FDA Advisory Committee Recommendation Regarding Liprotamase New Drug Application for Treatment of Exocrine Pancreatic Insufficiency
Date:1/12/2011

INDIANAPOLIS, Jan. 12, 2011 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee voted today to recommend non-approval of liprotamase, a non-porcine pancreatic enzyme replacement therapy (PERT), currently under FDA review for the treatment of exocrine pancreatic insufficiency (EPI).

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.  

"We appreciate the feedback the committee has provided, and we will continue to work with the FDA to address the questions raised in the meeting as the agency moves toward a final decision on the application," said Eiry Roberts, M.D., Vice President, Autoimmune, Bone-Muscle-Joint, Liprotamase Product Development at Lilly. "We remain confident in the clinical trial data package submitted to the FDA in support of the liprotamase application."

The FDA is not required to follow the recommendation of its advisory committees.

About Liprotamase & Pancreatic Enzyme Replacement Therapy

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. PERT is a treatment involving the oral administration of pancreatic enzyme replacements, which include protease, amylase and lipase.

Patients with EPI cannot properly digest and absorb nutrients including fat, protein and carbohydrates. Causes of EPI include cystic fibrosis (a life-threatening genetic disorder), chronic pancreatitis and pancreatectomy (surgical removal of the pancreas).

Cystic fibrosis affects approximately 30,000 children and adults in the United States and
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SOURCE Eli Lilly and Company
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