Pozen wins at FDA’s regulatory briefing
Executive Summary
FDA finds endoscopic gastric ulcer incidence to be an acceptable primary endpoint for Pozen's combination naproxen/esomeprazole product, PN 400. FDA had undertaken a review of the clinical trial design that could have forced Pozen to redo its clinical trials; an NDA submission is now planned for 2009 (1"The Pink Sheet" DAILY, Oct. 17, 2008). The issue of whether to accept the gastric ulcer endpoint was to be the subject of an FDA regulatory briefing earlier this year (2The RPM Report, November 2008). FDA is continuing to review possible changes to clinical trial requirements for combination NSAID/proton pump inhibitors (3"The Pink Sheet," Nov. 17, 2008, p. 31)
You may also be interested in...
FDA Raising Approval Bar For NSAID/PPI Combos; Endpoints Under Review
FDA is considering changes to the approval process for NSAID and proton pump inhibitor combination products that may result in the agency prohibiting the use of endoscopic gastric ulcer reduction to support a gastroprotective marketing claim
Pozen/AZ Combo Pill Could See Setback As FDA Reviews Trial Endpoints
Phase III studies of the NSAID/PPI combination are set to wrap up, but agency now is reviewing use of endoscopic gastric ulcers as an endpoint.
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.