Cardiovascular panel relents
BETHESDA, Md. - The Cardiorenal Drugs Advisory Committee's 8-2 vote last week to recommend approval of SmithKline Beecham's Coreg (carvedilol) could be good news for Intercardia Inc., which is conducting Phase III trials of a similar drug, bucindelol. Coreg and bucindelol are third generation non-specific beta blockers, with vasodilating and antioxidant properties.
This is the second go-round for Coreg. Last May, the FDA panel (CDAC) recommended that the agency not approve Coreg. That decision significantly cut Coreg's lead over bucindolol. Intercardia (ITRC, Research Triangle Park, N.C.), which is majority owned by Interneuron Pharmaceuticals Inc. (IPIC, Lexington, Mass.), began Phase III