First GLP-1/GIP Receptor Agonist OK’d for Kind 2 Diabetes

The FDA current first-in-class tirzepatide (Mounjaro) for patients with kind 2 diabetes, the company launched on Friday.

Tirzepatide, a glucagon-love peptide-1 and glucose-dependent insulinotropic polypeptide (GLP-1/GIP) agonist, is straight away accessible at three dose levels (5 mg, 10 mg, and 15 mg), would possibly possibly possibly also still be administered by means of injection as soon as weekly, and is indicated as an adjunct to weight-reduction contrivance and divulge.

In five clinical trials in the SURPASS program, tirzepatide alone or as an add-on treatment proved better for HbA1c bargain versus long-acting insulin degludec or insulin glargine, the GLP-1 receptor agonist semaglutide (Ozempic), or placebo.

“Given the challenges many patients ride in reaching their purpose blood sugar targets, as we narrate’s approval of Mounjaro is an major advance in the treatment of kind 2 diabetes,” mentioned Patrick Archdeacon, MD, of the Division of Diabetes, Lipid Considerations, and Obesity at FDA’s Heart for Drug Review and Research, in a assertion.

When compared with placebo, patients randomized to essentially the most urged dose of tirzepatide (15 mg) saw their HbA1c levels reduced by an absolute 1.6% when ragged as a stand-alone treatment, and by 1.5% when ragged along with a protracted-acting insulin. And when compared with active brokers, patients on tirzepatide at the 15-mg dose had their HbA1c reduced by 1.0%, 0.9%, and nil.5% bigger than with insulin glargine, insulin degludec, or semaglutide, respectively.

Most members in the pains had weight problems, with an sensible BMI of 32-34 across the stories at enrollment, nonetheless patients randomized to the GLP-1/GIP agonist experienced vastly more weight reduction with the drug versus these assigned to placebo groups: a 15-lb increased bargain when tirzepatide became ragged as stand-alone treatment and a 23-lb increased bargain when blended with insulin.

And mean weight reduction with tirzepatide at essentially the most dose became 12 lb, 29 lb, and 27 lb increased than with semaglutide, insulin degludec, and insulin glargine, respectively.

FDA eminent plenty of unfavorable events observed in the SURPASS trials, along with “nausea, vomiting, diarrhea, lowered appetite, constipation, upper abdomen discomfort and abdomen ache.”

The company additionally cautioned that thyroid C-cell tumors were observed in rat stories, though it remains unknown whether here is a likelihood in humans. Regardless, patients with a history of medullary thyroid cancer (or a family history) and these with a pair of endocrine neoplasia syndrome kind 2 would possibly possibly possibly also still now not be prescribed the GLP-1/GIP agonist.

Tirzepatide is now not indicated for patients with kind 1 diabetes, the company identified, and has now not been studied in these with a history of pancreatitis.