semaglutide fda weight loss A big win for Wegovy: drug first in history to gain approval for reducing heart risks Ozempic® GLP for Weight Loss

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Semaglutide (Ozempic/Wegovy) Timeline Phase 3 trials began: 2015 (SUSTAIN program for diabetes) FDA approval (Ozempic for diabetes): December 2017 Commercial availability: Early 2018 Wegovy (obesity indication) Phase 3: 2018-2020 (STEP program) Wegovy FDA approval: June 2021 Wegovy commercial launch: September 2021, immediately went into shortage due to overwhelming demand Stable widespread availability: Mid-2023 (after Novo Nordisk scaled up manufacturing) Total time from Phase 3 start to stable availability: About 8 years for diabetes indication, 5 years for obesity indication (but with significant supply constraints)

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