FDA Remains Inconclusive on the Shortage Condition of Tirzepatide from Lilly

FDA Remains Inconclusive on the Shortage Condition of Tirzepatide from Lilly

FDA Remains Inconclusive on the Shortage Condition of Tirzepatide from Lilly

Eli Lilly’s tirzepatide for weight loss currently remains uncertain as the FDA reviews its supply situation and contemplates declaring a shortage, revealed a court status report Thursday.

The FDA has reportedly made “significant progress” in its evaluation of the previous decision to remove tirzepatide from the list of drugs in shortage and is focused on issuing a new decision, as noted in the report. A follow-up court status report is anticipated on December 19, 2024, or within a week following the FDA’s decision, whichever occurs first.

This latest update suggests that “the FDA has consented to refrain from taking action against tirzepatide compounders until December 19, unless an earlier decision on remand arises,” as stated in a note from Michael Chern, an analyst at Leerink Partners. He pointed out that this could positively affect various compounding businesses.

Last month, the FDA officially announced that the shortage of tirzepatide—marketed as Mounjaro for type 2 diabetes and Zepbound for chronic weight management—had been resolved. Previously, the product had remained on the FDA’s shortage list for several months as the company struggled to align its manufacturing capacity with rising demand for obesity treatments.

However, this decision effectively prevented compounding pharmacies from creating their own versions of tirzepatide, a move met with discontent by the Outsourcing Facilities Association (OFA). The OFA promptly criticized the FDA’s ruling, labeling it “arbitrary” and noting that it could deny patients essential treatment for type 2 diabetes and obesity.

The OFA filed a lawsuit against the FDA, claiming the removal of tirzepatide from the shortage list lacked “any semblance of lawful process.” The complaint highlighted Congressional allowances for certain drugs to be compounded when supplies are limited, which aims to ensure continued access to therapies for patients in need.

In its lawsuit, the OFA asserted, “Patient demand has been satisfied in precisely the manner Congress contemplated.” In the latest court update, the OFA stated that it has been continuously monitoring market conditions for tirzepatide to assist FDA decision-making and provide “evidence that the drug remains in shortage.”

“Survey data from this month shows increasing numbers of patients unable to obtain branded GLP-1 agonist products, including specifically branded Tirzepatide products,” the OFA reported, indicating that pharmacies and distributors are listing branded Tirzepatide products as out-of-stock or available in limited quantities.

Meanwhile, Lilly has firmly opposed compounded versions of tirzepatide. Recently, the company sued three retailers for allegedly selling altered tirzepatide. Lilly initiated similar legal actions in September 2023 and October 2023, continuing its legal actions into June 2024.

In a note from Thursday, BMO Capital Markets analyst Evan Seigerman remarked that the court update “provides little clarity on the path forward for Lilly’s ongoing battle with compounders.” Nevertheless, the firm maintains that despite potential “uncertainty” surrounding the lawsuit and the status of tirzepatide, Lilly’s future prospects remain bright.

“With capacity continuing to expand, we expect that challenges from compounders will diminish in the medium term, even if the FDA’s shortage decision experiences a reversal in the near future,” Seigerman concluded.