Re:To improve medical trials, justify exclusion criteria
by vericiab on Tuesday April 26, 2022 @04:57PM
(#31173078)
>The FDA approved Tezpire as a breakthrough drug for asthma in December 2021. Tezspire excluded morbidly obese people from their efficacy trials.
This statement is very misleading because morbidly obese people were only excluded from the Phase 2 PATHWAY trial[1] and were not excluded from the larger Phase 3 NAVIGATOR trial[2]. The FDA approved Tezpire based on both trials demonstrating efficacy, not just the PATHWAY trial.
This statement is very misleading because morbidly obese people were only excluded from the Phase 2 PATHWAY trial[1] and were not excluded from the larger Phase 3 NAVIGATOR trial[2]. The FDA approved Tezpire based on both trials demonstrating efficacy, not just the PATHWAY trial.
[1] https://clinicaltrials.gov/ct2/show/NCT02054130
[2] https://clinicaltrials.gov/ct2/show/NCT03347279