Solvay Pancreatic Enzyme Creon May Set Class Labeling With Infection Warning
Executive Summary
Solvay's post-marketing requirements will likely include ongoing surveillance of viruses in patients taking porcine-derived Creon and in the swine that produce it
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New Drug Approvals & Regulatory Updates, In Brief
Solvay's swine-based pancreatic enzyme product approved with REMS: On May 1 FDA granted Solvay Pharmaceuticals' Creon (pancrelipase) the first pancreatic enzyme insufficiency product approval under guidelines that bring the previously unregulated remedies under the FDA umbrella. At the same time the agency made clear its concerns for the class by requiring that CREON have a Risk Evaluation and Mitigation Strategy. As part of the classwide REMS, caregivers and patients are to receive a Medication Guide with dosing and safety information that emphasize the risk of fibrosing colonopathy, a rare adverse reaction in cystic fibrosis patients taking high doses of pancreatic enzyme replacement therapy, as well as the dangers of over- or under-dosing. It also notes the theoretical risk of cross-species infection with porcine viruses because Creon and similar products are derived from pig pancreases (1"The Pink Sheet," Dec. 8, 2008, p. 6). FDA-approved Creon will be available in the third quarter, but the 20-year-old currently marketed formulation will remain available until the launch, the company said
New Drug Approvals & Regulatory Updates, In Brief
Solvay's swine-based pancreatic enzyme product approved with REMS: On May 1 FDA granted Solvay Pharmaceuticals' Creon (pancrelipase) the first pancreatic enzyme insufficiency product approval under guidelines that bring the previously unregulated remedies under the FDA umbrella. At the same time the agency made clear its concerns for the class by requiring that CREON have a Risk Evaluation and Mitigation Strategy. As part of the classwide REMS, caregivers and patients are to receive a Medication Guide with dosing and safety information that emphasize the risk of fibrosing colonopathy, a rare adverse reaction in cystic fibrosis patients taking high doses of pancreatic enzyme replacement therapy, as well as the dangers of over- or under-dosing. It also notes the theoretical risk of cross-species infection with porcine viruses because Creon and similar products are derived from pig pancreases (1"The Pink Sheet," Dec. 8, 2008, p. 6). FDA-approved Creon will be available in the third quarter, but the 20-year-old currently marketed formulation will remain available until the launch, the company said
Solvay Creon May Soon Find Competitors At The Trough
Following a successful advisory committee, Solvay's Creon appears likely to become the only pancreatic enzyme product on the market with an approved NDA - at least for a little while