The Food and Drug Administration on Wednesday approved Eli Lilly’s once-daily obesity pill targeting GLP-1, setting off a commercial fight with Novo Nordisk as the two metabolic drug giants seek to grab an increasing share of a market forecast to reach $100 billion a year by 2030.
Next week’s launch of Foundayo, known scientifically as orforglipron, will come four months after Novo’s Wegovy pill. Its entry could threaten the lead established by the oral version of the industry’s first incretin-targeting weight-loss shot.
Executives from both companies have been seeding the battle for months as Novo has touted oral Wegovy’s numerically higher weight-loss data and Lilly has pointed to Foundayo’s convenience in that it doesn’t need to be taken on an empty stomach.
Commercial access through insurers, telemedicine providers and cash-pay channels will also define the clash, with the last two distinctive to the obesity market — where patient demand is high but insurance coverage can be restrictive.
The two sides pledged to offer starter doses at $149 a month for cash-pay patients as part of a drug-price deal with the White House that exempted both companies from taxes. Lilly also will offer starter doses to insured people for $25 a month.
“As a convenient, once-daily oral pill that delivers meaningful weight loss, this is obesity care designed for the real world," said Lilly CEO David Ricks in a statement.
The indication for Foundayo is for people with obesity or are overweight and with weight-related health problems.
In its clinical trial, Foundayo helped people with obesity but without diabetes lose about 11% of their body weight at the highest dose, and people with obesity and diabetes lose about 10%. The Wegovy pill achieved weight loss of 14% on average, although the two drugs haven’t been tested head-to-head to determine superiority.
“Not all GLP-1s are the same. Any reports claiming orforglipron is more effective than Wegovy pill for weight management are inaccurate and misleading,” said Jamey Millar, Novo’s executive vice president for U.S. operations, in a statement.
Ahead of this oral drug showdown, Lilly had stolen Novo’s once-dominant position in weight-loss and diabetes treatment with its injectable medicine targeting GLP-1 and GIP, which is marketed as Zepbound for obesity and Mounjaro for diabetes. This effectively erased the first-mover advantage Novo established with its competing product, sold as Wegovy and Ozempic.
Both Foundayo and the Wegovy pill are poised to have significant uptake and reach blockbuster status, with Foundayo potentially becoming one of the biggest all-time sellers. RBC Capital Markets analyst Trung Huynh, for example, has predicted annual U.S. sales will reach $1.7 billion this year and peak at $36 billion.
