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Northfield Labs Eyes First Half 2008 For PolyHeme BLA Submission

This article was originally published in The Pink Sheet Daily

Executive Summary

The company will seek a priority review for the investigational red blood cell substitute.

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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

Northfield PolyHeme priority review status brings April user fee goal

Northfield Laboratories' PolyHeme application carries a user fee goal date of April 30 following FDA's designation of the BLA for priority review status. PolyHeme could be the first blood substitute on the market. The human hemoglobin-based red blood cell substitute seeks an indication for treatment of life-threatening RBC loss when an oxygen-carrying fluid is required and red blood cells are not available. The BLA is supported by a Phase III randomized, double-blind trial in 720 trauma patients (1"The Pink Sheet" DAILY, Aug. 15, 2007)

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