Pargluva Rejection Urged By Public Citizen
This article was originally published in The Pink Sheet Daily
FDA advisory committee's recommendation for approval of Bristol-Myers Squibb's diabetes agent was "inappropriate" because it was based on "vague promises" from industry, Public Citizen says in a letter to the agency.
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Regulatory approval and commercial success of the investigational type 2 diabetes drug will require additional clinical trials that could take up to five years to complete, Bristol says.
Committee supports use of the type 2 diabetes therapy muraglitazar as monotherapy and in combination with metformin, but says safety with sulfonylureas has not been adequately studied.
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