Diabetes Drugs: US FDA Advice On Premarketing Safety Database Raises Industry Concerns
Executive Summary
A draft guidance recommendation for 4,000 patient-years of exposure in Phase III, including at least 1,200 patients with comorbid conditions, is too proscriptive, unnecessarily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.
You may also be interested in...
Diabetes Drugs: US FDA Proposes Hypoglycemia Efficacy Endpoints, With Limits
Reduction in the risk of hypoglycemia level 2 and 3 events, along with either a reduction or maintenance of an acceptable hemoglobin A1C, is a clinically relevant efficacy endpoint for drug development in Types 1 and 2 diabetes, FDA states in new draft guidance.
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.
Diabetes Drugs: Longer, Broader Phase II/III Trials Could Replace CV Outcomes Trials, US Panel Says
Premarketing trials that enroll more diverse patient populations and include targeted CV endpoint collection over longer periods of time could be sufficient to allow new type 2 diabetes drugs to reach market without need for a dedicated safety study, advisory committee members say, urging FDA to move away from current two-step approach to cardiovascular risk assessments.