Cystic Fibrosis: Eurand Launches Zenpep, Joins Breed Of Remade Pancreatic Enzyme Products
This article was originally published in The Pink Sheet Daily
Rival's claim that porcine-derived product trials took only treatment responders is "baloney," says Eurand lead investigator.
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Alnara claims its latest trial shows real-world effectiveness of liprotamase, formerly called Trizytek, and plans early 2010 NDA.
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
FDA is not removing unapproved products from the market because they are medically necessary. However, manufacturers must obtain approval of exocrine pancreatic insufficiency drugs within four years.