The FDA cleared Novo Nordisk’s oral semaglutide formulation for weight loss, granting the company the first approved oral GLP‑1 drug for obesity in the U.S. The approval follows pivotal trials showing significant weight loss versus placebo and covers indications for reducing major cardiovascular events in addition to weight management. Novo Nordisk plans an early January commercial launch for the once‑daily tablet. Regulators approved the pill after phase 3 data demonstrated weight reductions comparable to injectable semaglutide doses in key endpoints; safety profiles were consistent with the GLP‑1 class, notably gastrointestinal side effects. Oral GLP‑1s remove the injection barrier for many patients and could broaden market access and prescribing patterns. For drugmakers and payers, the approval accelerates competition and reimbursement debates in the obesity drug market.
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