FDA Drug Approvals, Endocrinology — 2022 Midyear Review

August 24, 2022

Mounjaro (tirzepatide)

Tirzepatide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It acts by dually targeting glucagonlike peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). GIP is an incretin hormone that induces insulin secretion in response to a meal (primarily by hyperosmolarity of glucose in the duodenum) to facilitate the metabolism of carbohydrates, fats, and proteins. GLP-1 receptor agonists increase insulin secretion in the presence of elevated blood glucose, suppress glucagon postprandially, delay gastric emptying to decrease postprandial glucose, and decrease glucagon secretion.

The SURPASS clinical trials investigated the use of tirzepatide. SURPASS-2 was an open-label, 40-week, phase 3 trial. The comparison by Frias et al of tirzepatide versus semaglutide in patients with type 2 diabetes mellitus (SURPASS-2) found that tirzepatide at all doses was noninferior and superior to semaglutide in lowering HbA1c. Tirzepatide was also superior to semaglutide in body-weight reductions. N Engl J Med 2021 Aug 5;385(6):503-515

Other endocrinology approvals

Imcivree (setmelanotide) – Indication for chronic weight management in patients aged 6 years and older with obesity caused by certain genetic disorders expanded to include Bardet-Biedl syndrome.

Qsymia (phentermine/topiramate) – Indication for chronic weight management expanded to include adolescents aged 12 years and older with an initial BMI in the 95th percentile or greater for age and sex.


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