FDA approves new drug for type 2 diabetes: Mounjaro

FDA approves new drug for type 2 diabetes: Mounjaro
  • The FDA recently approved Mounjaro, also known as tirzepatide, for adults with type 2 diabetes.
  • Mounjaro is an injectable prescription medication intended to be used along with diet and exercise to improve blood sugar control.
  • Initial findings indicate that this drug could be an invaluable asset in the treatment of adult patients with type 2 diabetes.

The United States Food and Drug Administration (FDA) recently approved Mounjaro, also known as tirzepatide, for adults with type 2 diabetes.

Monjaro is a injectable prescription drug intended to be used in conjunction with diet and exercise to improve blood sugar control.

Initial findings indicate that this drug could be a invaluable asset in the treatment of adult patients with type 2 diabetes.

Why was it approved?

Mounjaro’s approval was based on the results of the program SURPASS of phase 3, which compared it with competitors such as the semaglutide injectioninsulin glargine and insulin degludec.

“Mounjaro delivered superior and consistent A1C reductions against all comparators throughout the SURPASS program, which was designed to evaluate the efficacy and safety of Mounjaro in a wide range of adults with type 2 diabetes who could be treated in clinical practice” said Juan Pablo Frías, Medical Director of the National Research Institute and Researcher of the SURPASS program, in a press release.

“The approval of Mounjaro is an exciting step forward for people living with type 2 diabetes, given the results seen in these clinical trials.”

Mechanism of action

Glucagon-like peptide-1 (GLP-1) and insulinotropic polypeptide Glucose-dependent (GIP) are hormones involved in the control of blood glucose. GLP-1 receptor agonists act by stimulating insulin secretion during episodes of hyperglycemia.

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GLP-1 receptor agonists also suppress the glucagon secretion, delay gastric emptying, suppress appetite and reduce body weight. Unlike GLP-1, GIP is glucagonotropic. In the presence of high blood sugar levels, GIP stimulates the release of insulin and lowers glucagon levels. Under conditions of low blood sugar, GIP leads to increased glucagon levels.

Mounjaro is a first-class drug that acts as a dual GIP-GLP-1 receptor agonist.

Its structure is based on the GIP amino acid sequence. It has a half-life of approximately 5 days which allows subcutaneous injections once a week.

Mounjaro effectiveness

Five clinical trials evaluated the effectiveness of Mounjarowhen administered in three different doses (5 milligrams, 10 milligrams, and 15 milligrams).

The patients who were randomly assigned to receive 15 milligrams of Mounjaro as stand-alone therapy lowered their hemoglobin A1c (HbA1c) by 1.6% more than placebo. When used in combination with a long-acting insulin, they lowered their HbA1c by 1.5% more than placebo.

Clinical trials comparing Mounjaro with other FDA-approved diabetes drugs have also shown promise.

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The side effects Common symptoms of Mounjaro include nausea, diarrhea, vomiting, decreased appetite, constipation, and abdominal pain.

Studies have shown that Mounjaro can cause thyroid C-cell tumors in rats. However, it is not clear whether Mounjaro causes similar tumors, including medullary thyroid cancer, in humans.

Mounjaro should not be used by patients with a personal or family history of medullary thyroid cancer, or patients with Multiple Endocrine Neoplasia type 2 syndrome.

Mounjaro is not indicated for use in patients with type 1 diabetes and has not been studied in patients with a history of pancreatitis.

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