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FDA Approves Dual Treatment For Type 2 Diabetes

Author: Medical Team (Alniche Life Sciences)


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Diabetes mellitus has been recognized as one of the four non-communicable diseases that requires urgent attention for prevalence and its associated complications and comorbidities.

May 2022, the US Food and Drug Administration approved Mounjaro (Tirzepatide) injection to improve sugar level in adults with type 2 diabetes, as an addition to diet and exercise.

US pharma major Eli Lilly’s Mounjaro was effective at improving blood sugar and was more effective than the other diabetes therapies with which it was compared in clinical trials studies.

“Type 2 diabetes is a chronic and progressive condition that requires continued innovation to help people manage their blood glucose and weight," Mike Mason, president, Lilly Diabetes, said in a statement.

Diabetes is considered as a top 10 cause of death globally, killing about 1.6 million people worldwide has highest risk factor mortality due to hyperglycemia and associated oxidative stress and inflammation.

According to the International Diabetes Federation (IDF), 8.8% of the adult population have diabetes, with men having slightly higher rates (9.6) than women (9.0%). Current global statistics shows that 463 million and 374 million individuals have diabetes and impaired glucose tolerance(IGT), prediabetes condition.

“Given the challenges many patients experience in achieving their target blood sugar goals, today’s approval of Mounjaro is an important advance in the treatment of type 2 diabetes,” said Patrick Archdeacon, M.D., associate director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research.

Despite the provision of many medications to treat diabetes, many patients do not achieve the recommended blood sugar goals.

Glucagon-like peptide-1 (GLP-1) and glucose-dependent insulin tropic polypeptide (GIP) are hormones involved in blood glucose management. Mounjaro (tirzepeptide) is a first-in-class medicine that activates both the GLP-1 and GIP receptors, which results in improved blood sugar. Mounjaro is administered by injection under the skin once weekly, with the dose adjusted as tolerated to fulfill blood sugar goals.

Clinical trial results show the drug is effective at improving blood sugar more effectively than other diabetes therapies. A total of 3 doses (5 mg, 10 mg, and 15 mg) of the treatment were evaluated in a total of 5 clinical trials

Glucagon-like peptide-1 (GLP-1) lowers blood glucose, together with stimulating insulin secretion and suppressing glucagon secretion during hyperglycemia.

Mounjaro has not been studied in patients with a history of pancreas inflammation (pancreatitis), for this condition it is not indicated for use in patients with type 1 diabetes.

Tirzepatide received priority review for this indication, which directs overall attention and resources to the evaluation of drug if approved, would be significant improvement in the safety and effectiveness of the treatment, diagnosis or prevention of serious conditions. ­­­