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FDA approves tirzepatide for type 2 diabetes treatment

DTMT Network

The United States Food and Drug Administration has approved Eli Lilly’s tirzepatide marked as Mounjaro injection to improve blood sugar control in adults with type 2 diabetes.

In a statement on May 13, 2022, the drug regulator said that the drug was effective at improving blood sugar and was more effective than the other diabetes therapies with which it was compared in clinical studies.  

“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,” Dr Patrick Archdeacon, the associate director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research said.

According to various estimates, type 2 diabetes, which accounts for 95% of all diabetes affected more than 500 million adults worldwide in 2021 and is expected to reach 610 million by 2030.

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

The FDA informed that three different doses of Mounjaro (5 milligrams, 10 milligrams and 15 milligrams) were evaluated in five clinical trials as either a stand-alone therapy or as an add-on to other diabetes medicines and the drug’s efficacy was compared to placebo, a GLP-1 receptor agonist (semaglutide) and two long-acting insulin analogues.

The results of the trial showed that the drug was able to lower haemoglobin A1c by 1.6% compared to placebo when used as a standalone therapy and 1.5% when used along with long-acting insulin.

In trials comparing Mounjaro to other diabetes medications, patients who received the maximum recommended dose of Mounjaro had a lowering of their HbA1c by 0.5% more than semaglutide, 0.9% more than insulin degludec and 1.0% more than insulin glargine, FDA said.

It may be recalled that the drug was also found effective in reducing weight by 22.5% and the average weight loss with the maximum recommended dose of Mounjaro was 5.4 kg more than semaglutide, 13.15 kg more than insulin degludec and 12.24 kg more than insulin glargine. Those patients receiving insulin without Mounjaro tended to gain weight during the study.

“Mounjaro delivered superior and consistent A1C reductions against all of the comparators throughout the SURPASS program, which was designed to assess Mounjaro's efficacy and safety in a broad range of adults with type 2 diabetes who could be treated in clinical practice,” Dr Juan Pablo Frías, the Medical Director of National Research Institute and investigator in the trial program said in a statement.

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

“We are thrilled to introduce Mounjaro, which represents the first new class of type 2 diabetes medication introduced in almost a decade and embodies our mission to bring innovative new therapies to the diabetes community,” Mike Mason, president of Lilly Diabetes said.

However the drug can cause nausea, vomiting, diarrhoea, decreased appetite, constipation, upper abdominal discomfort and abdominal pain and have been found to cause thyroid C-cell tumours in rats, FDA said.

Furthermore, it has not been studied in patients with a history of pancreas inflammation, and it is not indicated for use in patients with type 1 diabetes, the drug regulator said.


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