Eli Lilly said its experimental weight-loss pill orforglipron qualifies for most criteria under the U.S. Food and Drug Administration’s new national-priority voucher program, positioning it for a potentially accelerated approval timeline. The company will file for review this quarter, with the FDA set to determine whether the drug earns a fast-track pathway that could shorten approval to as little as one to two months — instead of the typical 10-12 months.
Introduced in June, the FDA program speeds up review for medicines that address major health challenges or manufacturing gaps in the U.S. Lilly said orforglipron meets three of the four criteria, supported by late-stage trial data showing average weight loss of 12.4% and significant investments in U.S. production capacity. The FDA recently issued its first nine priority vouchers to companies including Merck KGaA, Sanofi, and Regeneron.
Alongside the regulatory update, Lilly raised its full-year revenue and profit guidance after reporting stronger-than-expected third-quarter results, driven by robust overseas demand for its obesity treatments. Shares rose about 3% on Thursday. Analysts pointed to international sales of its Mounjaro obesity therapy — marketed as Zepbound in the U.S. and Mounjaro abroad — which came in nearly $1 billion above estimates, according to Guggenheim. Roughly three-quarters of overseas Mounjaro revenue came from patients paying out-of-pocket, a trend seen as strengthening Lilly’s position in the fast-growing global weight-loss drug market.
Eli Lilly, now the world’s most valuable healthcare company, continues to battle Novo Nordisk for leadership in the booming obesity drug sector, which analysts expect could top $150 billion by 2030. The company’s momentum comes as the Trump administration advances drug-pricing reforms intended to lower U.S. pharmaceutical costs in line with other developed economies.
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