Beyond the legal action, Eli Lilly is calling on healthcare providers, regulatory authorities, online platforms and even logistics companies to help stem the illegal sale of its next-generation asset for weight loss.
Eli Lilly is taking six U.S. entities to court for allegedly illegally selling the pharma’s next-generation weight loss candidate retatrutide.
The lawsuits target compounding pharmacies, medical spas and online sellers, which the pharma claims are advertising retatrutide for research purposes but in reality are providing the molecule for human use, according to a Wednesday morning announcement. Retatrutide is in Phase 3 development for obesity, with Lilly anticipating a regulatory filing early next year.
Aside from the lawsuits, Lilly has also referred more than 200 other players to U.S. authorities in an effort “to stop this illegal market” of retatrutide. Furthermore, the company has reported over 14,000 websites, social media posts, advertisements and online listings spanning more than 100 countries for illegal retatrutide sales.
Lilly is now calling for broader action against what it calls the “dangerous black market for retatrutide.” The pharma is urging regulatory authorities, law enforcement and other government bodies to approach the illegal sale of retatrutide as an “urgent public health crisis” facilitated by cross-border “criminal networks.” Social media and online commerce platforms should also do their part to stop enabling the black market and proactively block retatrutide sales, Lilly said.
The company cast its net widely, also urging action from consumers, doctors, credit card and payment service providers and logistics companies.
Lilly has built a strong late-stage profile for retatrutide. Data released last month showed that a 12-mg dose of the drug can cut body weight by up to 22.6% at 80 weeks, as compared with 3% to 4% in placebo controls. The pharma is building up to an application package early next year, though it has yet to align with the FDA on how to exactly classify retatrutide—as a biologic or other drug class—and how long will it have market exclusivity if approved.
Lilly’s crackdown on the retatrutide black market comes after the pharma said earlier this month that it would give a few patients early access to the drug ahead of a potential FDA approval, according to reporting from Reuters. Only those 18 years and older who are unable to participate in an ongoing retatrutide trial will be eligible for the early-access program.
This development followed a June report from STAT News that an unnamed 79-year-old man had been given retatrutide through the FDA’s compassionate use program. Citing three anonymous sources familiar with the matter, STAT additionally noted that the patient made his request in April, a move that got the attention of top health authorities. The man’s identity remains unknown, though the publication pointed out that President Donald Trump was 79 at the time the request was made.
