Type 2 Diabetes Drugs Can Skip Cardiovascular Outcome Trials, But Phase III Must Be Longer, Broader
US FDA withdraws controversial 2008 guidance that required sponsors to exclude threshold levels of cardiovascular risk before and after approval; new draft guidelines emphasize duration of exposure and breadth of safety evaluations in more diverse Phase III trial population, consistent with advisory committee recommendations.
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A Matter Of Precedent: US FDA Sometimes Labors Under Weight Of Unpopular Or Unfavorable Decisions
As agency observers wonder whether and how political considerations will impact the timing of a COVID-19 vaccine approval or authorization, the Pink Sheet looks at instances through the years where agency staffers found themselves operating under precedents with which they disagreed or that didn’t work out as expected.
Diabetes Drugs: US FDA Advice On Premarketing Safety Database Raises Industry Concerns
A draft guidance recommendation for 4,000 patient-years of exposure in Phase III, including at least 1,200 patients with comorbid conditions, is too proscriptive, unnecessarily large and lacks justification, biopharma industry comments say.
Eli Lilly’s Trulicity’s Broad CV Label Spotlights GLP-1 Rivalry
Trulicity’s broad CV label awarded by the US FDA should aid overall uptake of the GLP-1 class, cushioning the direct impact on Novo Nordisk’s rival, Ozempic, analysts said.