Eli Lilly's weight-loss, diabetes drug shortage is resolved, says US FDA

The US Food and Drug Administration said on Thursday there was no longer a shortage of Eli Lilly's blockbuster weight loss and diabetes drugs following a re-evaluation of their supply by the agency. 

The finding effectively bars widespread sales of cheaper copies of the drugs that many patients use, but the FDA said it would not take any action against the compounding pharmacies that make them within 60 to 90 days of Thursday's decision. 

Compounding pharmacies were not given a notice period when the FDA first declared that the drugs were out of shortage in October, before announcing days later that it would reconsider its decision. 

US regulations allow compounding pharmacies to copy brand-name medicines that are in short supply. 

A Lilly spokesperson said anyone marketing or selling unapproved versions of tirzepatide, the chemical name for its weight-loss drug Zepbound and diabetes medicine Mounjaro, must now stop and begin transitioning patients to FDA-approved medicines. 

The Alliance for Pharmacy Compounding, which represents compounding pharmacists and technicians, said the announcement was not unexpected but "not necessarily the end of the story." "I'm just not persuaded that the data on which FDA is relying in this doubling-down on its shortage resolution decision is complete enough to say the shortage is really over," said Alliance CEO Scott Brunner. 

The FDA added that Novo Nordisk's rival weight-loss drug, Wegovy, was still in shortage, despite all doses being listed as available. The Alliance sent survey results to the FDA last month showing hundreds of thousands of patients were taking compounded versions of semaglutide, the chemical name for Wegovy, and said the agency should consider their role in alleviating the obesity drug supply crunch. 

Telehealth firm Hims & Hers Health, which offers compounded versions of Wegovy, declined to comment. Its shares, which have nearly tripled in value this year, closed 7.7 per cent lower at $26.36 on Thursday. 

Eli Lilly shares have risen 30 per cent so far this year, and closed down 0.9 per cent at $757.54. Shares of Danish drugmaker Novo Nordisk have risen 10.6 per cent this year and closed 3.7 per cent lower on Thursday. 

Bernstein analyst Courtney Breen said the FDA's decision suggests the end of "compounder-spree" was near, but that this will have only a modest impact on the drug's prescription volumes in 2025. 

Another industry group that represents larger compounding pharmacies sued the FDA in October over its decision to take tirzepatide off its list of drugs experiencing shortages. 

The Outsourcing Facilities Association claimed the FDA had made its decision based on Lilly's claims it could meet demand for the drugs, without giving the public a chance to weigh in. 

It said the drug remained in short supply. 

The lawsuit was put on hold days later after the FDA agreed to reconsider the decision, allowing sales of compounded versions to continue in the meantime. 

In a joint court filing on Thursday, both sides said they were working to agree on a schedule for the case to go forward. 

They said that if the Outsourcing Facilities Association files a motion asking the court to block the FDA's decision within the next two weeks, the agency has agreed not to take any enforcement action while the court considers it. 

Insurers generally cover Lilly's and Novo's drugs for diabetes, but many do not cover them for weight loss. That has led many patients to pay out of pocket for compounded versions. 

Lilly in August began sending cease-and-desist letters to telehealth companies, wellness centers and medical spas selling compounded versions of Zepbound and Mounjaro. The company has also filed lawsuits against sellers falsely claiming to sell FDA-approved versions of the drug. 

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