Eli Lilly says weight-loss pill a candidate for speedy approval under new US programme
Eli Lilly said its experimental weight-loss pill met most criteria for the US Food and Drug Administration’s new national priority voucher, suggesting it is a strong candidate for a significantly accelerated approval review.
Lilly said it will submit its review package for the pill, orforglipron, to the FDA this quarter, adding the agency will decide on the approval process.
In June, the FDA unveiled a program under which its commissioner can award vouchers to national‑priority drugs, shortening reviews to one to two months from about 10 to 12.
Priority criteria include innovative medicines, addressing health crises or unmet needs, and boosting domestic manufacturing. Lilly said it meets three of the four criteria.
The Indianapolis-based drugmaker’s experimental GLP-1 pill was shown to help patients lose 12.4% of their body weight in a late-stage study, and the company has pumped billions of dollars into new U.S. plants to manufacture it.
The FDA earlier this month announced the first nine recipients of the voucher program, which include Merck KGaA’s fertility drug Pergoveris, Sanofi’s Type 1 diabetes drug teplizumab, and a Regeneron drug for deafness.
Lilly also raised its full-year profit and revenue forecasts today, as strong overseas demand for weight-loss drugs from cash payers helped it breeze past Wall Street’s third-quarter earnings expectations.
Shares of the world’s largest healthcare company by market value were up 3% even as investors remain wary of drug price negotiations with the Trump administration.
“International Mounjaro demand was a strong driver of the beat and raise this quarter, which is a fantastic factor that shows the dynamicism of the Eli Lilly business model,” said Kevin Gade, chief operating officer at Bahl & Gaynor, which owns Lilly shares.
Guggenheim analysts said international Mounjaro sales came in nearly $1 billion above its estimates for the quarter. Mounjaro is the brand name used for treating weight loss and type 2 diabetes outside the U.S. It is sold as Zepbound for weight loss in the U.S.
A Lilly executive during a call to discuss its results said about three-quarters of Mounjaro revenue from outside the U.S. came from people with obesity paying out of pocket.
Lilly competes with Novo Nordisk for dominance in the weight-loss drug market, which some analysts project will reach $150 billion by the end of the decade.
Since returning to the White House in January, President Donald Trump has been striving to narrow the gap between what Americans pay for prescription medicines and drug prices in other developed nations, known as “most favored nation” policy.
Cantor analyst Carter Gould said while there remain some drug pricing overhangs to work through, Lilly had the strongest third-quarter earnings report he had seen so far.
