Lilly’s Mounjaro receives FDA approval for groundbreaking Type 2 diabetes treatment

26 Sep 2022 --- US-based Eli Lilly and Company has received US Food and Drug Administration (FDA) approval for Lilly’s Mounjaro, a tirzepatide injection treatment for Type 2 diabetes. The approval makes it the “first and only” FDA-approved gastric inhibitory polypeptide and glucagon-like-peptide-1 receptor agonist, expected to be available in the US in the coming weeks. 

“Mounjaro delivered superior and consistent A1C reductions against all of the comparators throughout the Surpass program (the trial), 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,” says Juan Pablo Frías, medical director at the National Research Institute and investigator in the program. 

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

The treatment showed effectiveness for blood sugar levels when acted alone or in combination with other diabetes treatments.Tirzepatide is currently under regulatory review in Europe, Japan and several other markets, the company notes. The products are expected to be available in the US soon but a release date has not yet been announced.

Contributors to approval
The results from the trial showed efficacy for different doses of Mounjaro when used alone or combined with other commonly prescribed diabetes medications such as metformin sodium-glucose cotransporter-2 (SGLT2) inhibitors, insulin glargine and sulfonylureas.

Available in six doses (2.5, 5, 7.5, 10, 12.5 and 15 mg), the trial showed A1C reduction rates between 1.8 to 2.1% for 5 mg and 1.7 to 2.4% for both those who consumed 10 mg and 15 mg.

The company highlights that the treatment is an adjunct to diet and exercise, which industry experts have highlighted previously. The Diabetes Atlas previously highlighted that by 2030, the number of adults with diabetes may reach 643 million, and by 2045 the number is expected to hit 784 million.

A public health concern
In the UK, one in ten is expected to have diabetes in 2030 unless rapid action is taken. Diabetes UK recently urged the government to intervene to improve access to weight management and nutrition.

Meanwhile, the UK government is being criticized for not implementing additional taxes on salt and sugar and prioritizing the food industry rather than public health. The new prime minister Liz Truss is currently facing pressure as she wishes to scrap the tax, described as “taking a U-turn” on tackling the obesity epidemic.Although the treatment is not intended for weight loss, significant results were found in the trial.

Additional effects found
The Eli Lilly and Company medication is not intended for weight loss, although the study showed weight reductions on a significant level. Those who consumed 10 mg lost an average of 5.4 kg, and those who consumed 15 mg lost an average of 11.3 kilos.

The trial period ranged from 40 to 52 weeks and was carried out globally, including participants diagnosed with diabetes for five to 13 years.

Side effects from the Mounjaro included nausea, diarrhea, decreased appetite, vomiting, constipation and abdominal pain, experienced by approximately 5%.

“Lilly has a nearly 100-year heritage of advancing care for people living with diabetes – never settling for current outcomes. We’re not satisfied knowing that half of the more than 30 million US citizens living with type 2 diabetes are not reaching their target blood glucose levels,” says Mike Mason, president of Lilly Diabetes.

“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,” he concludes.

Edited by Beatrice Wihlander