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.
You may also be interested in...
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.
The dual GLP-1/GIP agonist outpaced Novo's blockbuster GLP-1 analogue at all three doses, including the important low dose, on A1C reduction and weight reduction in patients with type 2 diabetes.