FDA: Solvay Pancreas Enzyme Drug Appears Safe Short-Term
The review, released Friday on the FDA's Web site, looked at Creon, a product already on the U.S. market. Creon and similar pancreatic-enzyme replacement products have been on the market for decades, prior to the enactment of rules in 2004 requiring manufacturers to seek approval to sell the products as prescription drugs.
The main concern with Creon and similar products is the fact that the pancreatic enzymes are derived from pig pancreas glands, providing a vehicle to potentially transmit viruses to humans.
Creon faces a review next Tuesday by an FDA advisory panel, which will mostly discuss steps that can be taken to reduce the risk of virus transmission. The agency said if traces of all viruses are eliminated in the manufacturing process it would also reduce the ability of the enzyme to work.
The FDA said the risk of infection associated with certain viruses contained in material used to make Creon "appears to be very low," but said the risk could be "further reduced" with additional testing and "ensuring limited patient exposure to these viruses." The agency said it will ask the panel for advice on what types of viruses the material used to make Creon should be tested for and what criteria should be used to release individual batches of material.
The main study submitted by Solvay in support of Creon looked at the product in 32 patients ages 12 to 43 with cystic fibrosis, a condition that causes lung damage and digestive problems from mucus that blocks the pancreas from releasing enzymes that help the body digest food. Creon is designed to replace those enzymes.
The FDA said the study showed Creon appeared effective at reducing gastrointestinal symptoms in patients, suggesting the product helped digest food. The agency also said Creon appeared safe in the short term, noting that there were more side effects reported among patients in the clinical trial who received a placebo drug than those receiving Creon.
Solvay is seeking FDA approval to market the drug in children and adults of all ages. The FDA said it will ask the panel for advice on whether the product should be marketed to children younger than 12 given that the main clinical trial looked at children ages 12 and older.
Solvay, in briefing materials also posted to the FDA's Web site, said it was currently studying Creon in children ages 6 to 11 and planned to start a study in infants and young children.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com
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(END) Dow Jones Newswires
November 28, 2008 12:05 ET (17:05 GMT)
Publié le 28 novembre 2008 Copyright © 2008 Dowjones
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