The FDA granted approval for a 7.2 mg high‑dose formulation of Novo Nordisk’s Wegovy (semaglutide) after an accelerated review enabled by a commissioner’s voucher, clearing the file roughly 54 days after submission. Novo framed the approval as part of a broader commercial response to competitive pressure from Eli Lilly’s obesity franchise; the higher dose produced stronger weight‑loss results in trials and narrows the efficacy gap with rival agents. The voucher program that expedited the review has drawn political scrutiny because it compresses standard timelines for files deemed to meet “national interest” criteria. Market analysts say the approval gives Novo an immediate tool to defend market share while pricing and payor dynamics remain uncertain.
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