WASHINGTON—Food and Drug Administration staff questioned whether a new type of a pancreatic-enzyme replacement product is as effective as products now on the market.
The agency posted a review of liprotamase, a product developed by Alnara Pharmaceuticals Inc., on its website Monday. Eli Lilly & Co. bought the company last year for an undisclosed amount.
Liprotamase, which has a proposed brand name of Solpura, faces a review Wednesday by outside medical experts on FDA’s gastrointestinal drugs advisory committee.
The panel will be asked to vote on whether it thinks liprotamase is safe and effective as well as whether additional studies should be conducted prior to approval. The FDA is not required to follow the advice of its advisory panels but usually does.
Liprotamase was developed to treat exocrine pancreatic insufficiency in children and adults caused by cystic fibrosis and other conditions. EPI is a lack of digestive enzymes made by the pancreas that results in the inability to properly digest food and absorb nutrients.
Unlike other pancreatic-enzyme replacement products, such as Solvay SA’s Creon, liprotamase was developed without using enzymes taken from the pancreas of the pig. FDA has said there’s a very small risk that viruses could be transmitted to patients with porcine-derived enzymes.
Alnara, in a background document prepared for Wednesday’s meeting, said studies of patients being given liprotamase show fewer pills are needed to deliver the enzymes compared to existing products. All pancreatic-enzyme replacement products are meant to be given with meals and snacks.
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