More than half of study participants receiving the dual incretin agonist had weight loss of 20% or greater, with no evidence of a plateau and only mild AEs.
In an unusual step, the agency's draft guidance recommends the efficacy benchmark for drug approval while emphasizing clinical trial structure and cohort development.
This marks the second indication for tirzepatide in just more than a year, following its November 2023 approval for adults with obesity or overweight and weight-related medical problems.