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The recently released approval letter sent to Lilly for the oral GLP-1 drug gives some insights into how the FDA will regulate new medicines approved via this rapid review pathway in practice
4 Related Stories Weight loss drugs may reduce binge eating disorder symptoms Single DNA injection provides long-lasting weight loss in mouse study Eight-hour eating window sustains long-term weight loss Mechanistically, binding to GLP-1R activates adenylate cyclase (AC), subsequently increasing cAMP to trigger both protein kinase A (PKA) and exchange protein directly activated by cAMP 2 (Epac2)
Retatrutide is primarily being developed for obesity treatment, with TRIUMPH trials focusing on weight loss in people with and without diabetes
1 Behind the scenes, though, GLP-1s are raising difficult questions about who has access to the drugs, the long-term health effects and how much the growing demand will drive up health spending
Disclosures/Conflicts of interest The authors whose names are listed immediately below certify that they have no affiliations with or involvement in any organization or entity with any financial interest or non-financial interest) in the subject matter or materials discussed in this article
