Novo Nordisk has asked the FDA to prohibit the compounding of semaglutide, ramping up the company’s fight against pharmacies distributing their own versions of the blockbuster weight loss and diabetes drug.
Pharmacies are allowed to distribute compounded versions of a drug in specific circumstances, as long as the product doesn’t demonstrate “difficulties for compounding” that could reasonably impact safety or efficacy. Novo Nordisk argued on Tuesday that semaglutide’s complexity raises “serious concerns” about compounded products, and asked the FDA to put the drug on its “Demonstrable Difficulties for Compounding” lists.
Eli Lilly issued a similar request in August for its rival dual GIP/GLP-1 drug tirzepatide, though the FDA has yet to take action, according to a Lilly spokesperson.
The move builds on Novo’s extensive legal campaign against compounding pharmacies, medical spas and weight loss clinics. The company has filed 50 lawsuits, including more than a dozen in the last couple months.
A Novo spokesperson said the company’s latest request was “driven by our concern for patient safety,” citing risks around unknown impurities, incorrect strengths and “even instances where no semaglutide was present in the product at all.”
But compounders continue to question drugmakers’ ability to meet high demand for GLP-1 drugs. The lowest dose of Novo’s Wegovy remains in “limited availability,” according to the FDA’s drug shortage database. And while the FDA recently removed tirzepatide from its shortage list, the agency said earlier this month that it will reconsider the decision following pressure from a trade group representing large compounding pharmacies.
“It’s kind of curious that at a time when Novo can’t meet patient need, it is going to FDA to ask that the API be placed off limits for compounding,” Alliance for Pharmacy Compounding CEO Scott Brunner told Endpoints News. “What Novo is saying, basically, is ‘It’s ours, and even though we can’t produce it right now for you, we don’t want anybody else to.’”
When asked about its ability to meet demand, the Novo spokesperson said the company’s “commitment to meeting demand is reflected in our significant investments in expanding our manufacturing capabilities.”
“We’ve managed shipments of the 0.25 mg starting dose of Wegovy responsibly to initiate patients on treatment, reflecting our commitment to patient care continuity,” the spokesperson said.
For now, Brunner said nothing changes for compounding pharmacies. If it decides to move forward, the FDA would convene an advisory committee to discuss the request. The FDA did not respond to a question about whether it will propose adding semaglutide to its “Demonstrable Difficulties for Compounding” lists.
Editor’s Note: This story has been updated to include comment from Eli Lilly on the status of its request to add tirzepatide to the FDA’s “Demonstrable Difficulties for Compounding” list.