Lilly filed Mounjaro application for type 2 diabetes in September 2021
The tirzepatide filing covered blood sugar control in adults with type 2 diabetes and came with long-term safety studies the FDA required after approval.
Eli Lilly submitted a new drug application for Mounjaro (tirzepatide) injection on September 14, 2021, and the FDA recorded receiving it on September 15, 2021, according to the agency's approval letter for the application [1]. The filing, NDA 215866, sought approval of the drug as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [1].
Mounjaro is the brand name for tirzepatide, given by injection [1]. The application covered type 2 diabetes; the approval letter describes no other use for the product [1].
The FDA later approved the application. The letter is signed May 13, 2022, and states the drug is approved effective that date for use as recommended in the agreed labeling [1]. The agency did not send the application to an advisory committee of outside experts, saying outside expertise was not necessary and there were no issues that would benefit from that discussion [1].
The approval also set a shelf life and attached several required studies. Based on the stability data submitted, the letter establishes an expiry dating period of 24 months from the date of manufacture when the product is stored at 2 to 8 °C [1].
Three postmarketing commitments are spelled out in the letter:
- A pediatric study for ages 10 to 17 was deferred because the product was ready for approval in adults and the pediatric study had not been completed. The required study is a 30-week randomized, double-blind, placebo-controlled, multicenter, parallel-arm trial of safety and efficacy in type 2 diabetes, followed by a 22-week open-label extension, with study completion scheduled for December 2027 and the final report due September 2028 [1].
- A registry-based case series on medullary thyroid carcinoma, a type of thyroid cancer, running at least 15 years, to monitor annual incidence in the United States and identify any increase related to tirzepatide entering the market. Study completion is scheduled for June 2039 and the final report for June 2040 [1].
- A milk-only lactation study in women who received a dose of tirzepatide, measuring drug concentrations in breast milk with a validated assay. Study completion is scheduled for July 2024 [1].
The timetable for these postmarketing studies was submitted to the FDA on April 14, 2022 [1]. The letter does not state a price, insurance coverage, or a launch date for Mounjaro; those have not been disclosed in it [1].
Why it matters for patients
For adults with type 2 diabetes, the application and approval added another prescription option, cleared specifically for blood sugar control rather than weight loss [1].
The studies required at approval show which questions were still open when the drug reached the market. The 15-year thyroid cancer monitoring study means the FDA set up long-term tracking of medullary thyroid carcinoma cases rather than treating that risk as settled [1]. The lactation study means breast-milk exposure data were not complete at approval, with completion listed for July 2024 [1]. Use in children ages 10 to 17 had not been established, and those data were deferred to a study with completion listed for December 2027 [1].
The approval letter describes one indication, glycemic control in adults with type 2 diabetes, and does not mention weight-loss use or cardiovascular outcomes for this product [1].
What happens next
Dated milestones from the timetable in the letter [1]:
- November 2022: draft protocol for the thyroid cancer registry study.
- January 2023: draft protocol for the lactation study.
- May 2023: final protocol for the thyroid cancer registry study.
- July 2023: final protocol for the lactation study.
- March 2024: first interim report for the thyroid cancer registry study, with interim reports each March through 2039.
- July 2024: lactation study completion.
- December 2027: pediatric study completion.
- September 2028: pediatric final report.
- June 2039: thyroid cancer registry study completion, with the final report due June 2040.
Sources
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