Panel Accepts FDA's Statistical Take On Micardis, Recommends Limited Use
Executive Summary
FDA's Cardiovascular and Renal Drugs Advisory Committee sided with FDA's more conservative statistical analysis of Boehringer Ingelheim's Micardis, rejecting the company's claim that telmisartan demonstrated non-inferiority to ramipril in a pivotal trial
You may also be interested in...
10,000 Re-Randomization Sequences Confirm Simponi Efficacy Results
Centocor demonstrated that an adaptive randomization technique provided comparable results to conventional randomization during pivotal trials for Simponi (golimumab)
10,000 Re-Randomization Sequences Confirm Simponi Efficacy Results
Centocor demonstrated that an adaptive randomization technique provided comparable results to conventional randomization during pivotal trials for Simponi (golimumab)
FDA, Boehringer Disagree On Non-Inferiority Margin For Micardis Prophylaxis
Agency will tell advisory committee that non-inferiority analysis should account for improvements in standard of care that change effect size.