The FDA approved Novo Nordisk’s once‑daily oral formulation of semaglutide (Wegovy) for weight management and cardiovascular risk reduction. The decision formalizes trial results showing up to ~16.6% mean weight loss at 64 weeks for the highest dose versus placebo and expands a market long dominated by injectable GLP‑1 agonists. Regulators cleared the pill with similar indications to the injectable, keeping safety warnings on gastrointestinal side effects. Novo Nordisk will launch the tablet in early January and expects the oral option to broaden patient access given easier administration and potentially lower logistics costs versus weekly injections. Clinicians say oral dosing could shift prescribing patterns and payer negotiations, increasing competition for both injectables and upcoming oral rivals. For drug development, the approval validates oral GLP‑1 delivery strategies and will likely accelerate rival programs and pricing discussions across the obesity and diabetes markets.
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