Statement From Lilly on FDA Advisory Committee Recommendation Regarding Liprotamase New Drug Application for 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.
"We appreciate the feedback the committee has provided, and we will continue to work with the
The
About Liprotamase & Pancreatic Enzyme Replacement Therapy
Liprotamase is an oral, non-porcine, pancreatic enzyme replacement therapy (PERT) under
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
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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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