FDA Panel Disapproves Pancreatic-Enzyme Replacement Product from Eli Lilly
FDA Panel Disapproves Pancreatic-Enzyme Replacement Product from Eli Lilly

An advisory panel of the Food and Drug Administration had voted 9-to-3 against drug, liprotamase manufactured by a unit of Eli Lilly & Co. saying that its medicinal effectiveness is not worth approval. Also, the panel voted 7-to-4 for the less benefits of the drug in comparison to risks it poses.

Liprotamase, which is a new type of pancreatic-enzyme replacement product, has been developed by Alnara Pharmaceuticals for the treat a condition in which exocrine pancreatic deficiency or EPI that are enzymes secreted by pancreases becomes deficient due to cystic fibrosis and leads to improper digestion of food and less absorption of nutrients.

The FDA panel based their decision on clinical data on the drug submitted by a manufacturer. The panel demanded more evidence to back the drug for its approval and its effectiveness in comparison to already available similar products.

The fate of the drug will be decided by the FDA in April. But, as per Lilly, they have full confident in the clinical data for liprotamase.

Liprotamase is not made of porcine-derived enzymes, which are found in other similar drugs such as Creon, so it is safer than them. Also, it just needs intake of one tablet per meal in case of liprotamase, while other drugs need to be taken in multiples. But, the FDA's panel main concern was its effectiveness in comparison to other similar drugs.

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