Determined to avoid a repeat of the supply shortfalls that plagued early GLP-1 rollouts for obesity, Eli Lilly has amassed a sizable store of its oral weight loss candidate orforglipron.
Specifically, Lilly had secured “pre-launch inventories” worth $1.5 billion as of Dec. 31, with most of that supply tied to orforglipron, the company said in a securities filing this week.
The update on Lilly’s pending launch inventory comes after the Indianapolis drugmaker said last February that it had built up nearly $550 million in early inventory that was again primarily related to orforglipron.
While it’s common for drugmakers to build up supplies of a medicine before an anticipated approval and launch, Lilly's early and aggressive stockpiling push for orforglipron suggests an effort to avoid a shortage shortly into the drug’s prospective debut, as happened with Lilly’s injectable GIP/GLP-1 drugs for diabetes and obesity, Mounjaro and Zepbound.
While both Lilly and its chief rival in the GLP-1 space, Novo Nordisk, have thoroughly resolved their supply constraints, those initial shortages helped spawn a cottage industry of weight loss drug compounders that has proven difficult to keep in check.
At the J.P. Morgan Healthcare Conference in January, Lilly’s chief scientist, Daniel Skovronsky, M.D., Ph.D., said his company planned to launch orforglipron “in many, many countries around the world, as quickly as possible,” according to Reuters.
Lilly is enjoying an expedited review timeline on orforglipron in the U.S. thanks to its receipt of an FDA Commissioner’s National Priority Voucher (CNPV) last November.
The pathway, which aims to significantly speed up the review of products “aligned with U.S. national health priorities,” has already faced lawmaker pushback about its potential to enable corruption and erode public confidence in the FDA’s review standards.
Still, despite the promise of a one- to two-month review timeline under the CNPV program, the FDA ultimately pushed its target decision date on orforglipron out to April 10, Reuters and other news outlets reported earlier this year.
Should it win approval, orforglipron will immediately go up against Novo Nordisk’s Wegovy pill for obesity, which was approved by the FDA in late December and launched in the U.S. in early January.
Despite a brief tangle with Hims & Hers—which attempted to launch its own compounded, GLP-1 containing pill just weeks into the debut of Novo’s product—the Wegovy pill has been tracking impressive prescription numbers, swiftly outpacing the launches of previous injectable GLP-1s for weight loss.