GSK Will Discuss COX-2 Trial Requirements With FDA
This article was originally published in The Pink Sheet Daily
Executive Summary
GlaxoSmithKline will meet with FDA to discuss clinical trial requirements for its Phase II dual acting COX-2 inhibitor 406381
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GlaxoSmithKline will meet with FDA to discuss clinical trial requirements for its Phase II dual acting COX-2 inhibitor 406381. "In the light of recent developments regarding a drug in the COX-2 class, GSK will be meeting with regulatory authorities to discuss their clinical trial requirements for '381 going forward," the company said in an Oct. 28 earnings release. Merck recently withdrew its COX-2 inhibitor Vioxx after finding increased risk of cardiovascular adverse events associated with the drug's use (1 (Also see "FDA Has One Month To Mull Approval Of Merck's Arcoxia Following Vioxx Withdrawal" - Pink Sheet, 30 Sep, 2004.)). During a same day conference call, CEO J.P. Garnier told investors he believes that the cardiovascular safety signal apparent in Vioxx "seems to be not necessarily a class effect." GSK said it would present data at an upcoming central nervous system R&D seminar. "You will hear stories about the distinctive features of the COX-2 and how it compares" in cardiovascular safety "at least in terms of the preclinical models," Garnier said. "We feel that those products are not all the same." GSK's announcement came the same day FDA issued Merck an "approvable" letter for its follow-on COX-2 Arcoxia (see 2 (Also see "Merck’s Arcoxia “Approvable” At FDA" - Pink Sheet, 29 Oct, 2004.)). - Lee Kalowski |