In 2023, NICE issued similar guidance for semaglutide, although this time, the duration of treatment was restricted to a maximum of two years and the drug could only be provided within a specialist weight management service
It works by simultaneously activating three incretin and metabolic hormone receptors: the glucagon-like peptide-1 (GLP-1) receptor, the glucose-dependent insulinotropic polypeptide (GIP) receptor, and the glucagon receptor
What Happened The FDA has updated Import Alert 66-80 , Detention Without Physical Examination (DWPE) of Drug Products Containing GLP-1 Receptor Agonists and Certain Peptide Drug Products, naming by drug substance semaglutide, tirzepatide, liraglutide, exenatide, dulaglutide, and retatrutide as well as broader peptide drug product codes (FDA Import Alert 66-80)
only the FDA has that authority.39 This preemption doctrine means a competitor cannot sue a compounder simply for violating FDA rules (like the essentially a copy provision)
Rodent models, in particular, raise concerns due to their limited translational relevance to human physiology