Bristol Expects FDA Advisory Committee Review Of Muraglitazar
This article was originally published in The Pink Sheet Daily
Executive Summary
Bristol-Myers Squibb expects FDA will hold an advisory committee meeting to discuss the application for its dual PPAR agonist muraglitazar
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Bristol-Myers Squibb expects FDA will hold an advisory committee meeting to discuss the application for its dual PPAR agonist muraglitazar. "Because of the general issues in this class - we're first in class here - we would expect an advisory committee to weigh benefit/risk issues," Bristol Research Institute President Elliott Sigal, MD/PhD, told investors Nov. 17 during the company's R&D Day in New York. The company maintains that muraglitazar has a favorable risk-benefit profile. However, a number of drugs in the dual PPAR class have been associated with carcinogenicity in rodents. Merck terminated MK-0767 due to carcinogenicity signals in animals in November 2003. In April, Merck paid Bristol $100 mil. up-front for muraglitazar co-promotion rights (1 (Also see "Merck Gets Second Chance On Dual PPAR: Will Co-Develop Bristol's Muraglitazar" - Pink Sheet, 28 Apr, 2004.)). FDA informed sponsors that Phase III trials lasting longer than six months could only be conducted if the sponsor demonstrated that tumors did not occur below 10-times the maximum recommended human dose in animal carcinogenicity studies. The agency will evaluate on a case-by-case basis if tumors are found at a nine-fold dose ("2 (Also see "FDA Delays PPAR Development Pending Carcinogenicity Tests, Ligand Says" - Pink Sheet, 9 Jul, 2004.)). "We started our carcinogenicity studies early and we have completed them," Sigal said. "We have been in conversations with the FDA and they do not require us to alter our clinical program," he said. Bristol noted that the tumor incidence associated with muraglitazar is either species-specific or found to occur at drug levels 48 times the recommended dose for humans. The company provided a glimpse of Phase III data demonstrating muraglitazar's efficacy at reducing A1C levels at both the 2.5 mg dose and 5 mg dose. Bristol will wait until the 2005 American Diabetes Association meeting to present the full Phase III data. The company expects to file the muraglitazar NDA by year-end. - Lee Kalowski |