Eli Lilly says weight-loss pill a candidate for speedy approval under new US program
By Mrinalika Roy and Patrick Wingrove
(Reuters) -Eli Lilly said on Thursday its experimental weight-loss pill meets most of the criteria for the U.S. 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, or forglipron, to the FDA this quarter, and the agency will decide on the approval process.
In June, the FDA announced a program under which the commissioner could grant coupons to national priority drugs and shorten the review period from about 10 to 12 months to one to two months.
Priority criteria include innovative medicines, addressing health crises or unmet needs, and increasing domestic production. Lilly said it met 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 factories in the U.S. to produce 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 Regeneron drug for deafness.
SHOOT AND RAISE
Lilly on Thursday also raised its full-year profit and revenue forecasts as strong overseas demand for its weight-loss drugs from cash payers helped it beat Wall Street’s third-quarter earnings expectations.
Shares of the world’s largest healthcare company rose 3 percent by market value even as investors remained wary of drug price negotiations with the Trump administration.
“International Mounjaro demand has been a strong driver of upside and downside growth this quarter, which is a great indicator of the dynamic of the Eli Lilly business model,” said Kevin Gade, chief operating officer of Bahl & Gaynor, which owns Lilly shares.
Guggenheim analysts said international Mounjaro sales came in about $1 billion above their estimates for the quarter. Mounjaro is the brand name used outside the United States to treat weight loss and type 2 diabetes. It is sold in the US as Zepbound for weight loss.
About three-quarters of Mounjaro’s revenue from outside the U.S. comes from obese people paying out of pocket, a Lilly executive said during a call to discuss the results.
Lilly is competing with Novo Nordisk for dominance in the weight-loss drug market, which some analysts predict will reach $150 billion by the end of the decade.
Since returning to the White House in January, President Donald Trump has sought to narrow the gap between what Americans pay for prescription drugs and drug prices in other developed countries, known as the “most favored nation” policy.
