LIS does not apply)
Reddy's submission and was reviewing eight other submissions for generic semaglutide from different companies
Semaglutide the active ingredient in Ozempic and Wegovy mimics GLP-1, a hormone the body naturally produces after eating
Subgroup and sensitivity analyses The primary outcome analysis was repeated across several subgroups inspired by the LEADER trial, defined by baseline characteristics: Sex (male/female), age (under 60/60 years or older), diabetes duration (11 years or less/more than 11 years), cardiovascular risk factors (presence of cardiovascular disease and age under 60/absence of cardiovascular disease and age 60 or older), prevalent heart failure status (yes/no), use of diabetes medication (one glucose-lowering co-medication/no co-medication/more than one glucose-lowering co-medication), HbA1c levels ( 60 years with a high risk of cardiovascular disease, those without heart failure, atrial fibrillation, and stroke, those with COPD, as well as all categories of baseline glucose-lowering therapy (Fig
Med 16 , 462468 (2015)
Is compounded tirzepatide the same as Mounjaro