Mounjaro is a once-weekly glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that comes in a single molecule. And it is available in a six-dose auto-injector pen with a pre-attached needle. The FDA's approval was based on Mounjaro's Phase III SURPASS programme.
The US Food and Drug Administration (FDA) has approved Eli Lilly and Company's Mounjaro (tirzepatide) injectables as an addition to nutrition and lifestyle in adult patients with type 2 diabetes to improve glycemic control. Mounjaro will be available in six doses: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg in an auto-injector pen with a hidden pre-attached needle.
The recent approval is based on results from the Phase III SURPASS study, which included active comparators such as injectable 1 mg semaglutide, insulin glargine, and insulin degludec. The study looked at the efficacy of Mounjaro dosages of 5, 10, and 15 mg alone and in combination with diabetes medications such as SGLT2 inhibitors, metformin, insulin glargine, and sulfonylureas. According to trial data, the average A1C reduction was between 1.8 and 2.1 percent for 5mg Mounjaro and between 1.7 and 2.4 percent for both 10 and 15mg dosages of Mounjaro.
Although the medication is not intended for weight loss, the mean change in body weight was a critical secondary outcome in all SURPASS trials. Mounjaro users shed an average of 12 lb (5mg) to 25 lb (15 mg). In addition to that, nausea, diarrhoea, decreased appetite, vomiting, constipation, indigestion, and stomach discomfort were reported by at least 5% of those in the Mounjaro arm. Mounjaro's labelling also includes a boxed warning about thyroid C-cell tumours.
"We're not satisfied knowing nearly half of the more than 30 million Americans living with type 2 diabetes are not attaining their optimal blood glucose levels," Mike Mason, Lilly Diabetes president, said.
"We are delighted to announce Mounjaro, which is the first new class of type 2 diabetes medication in nearly a decade and which exemplifies our aim to offer new innovative and revolutionary therapies to the diabetic community," says the company.
Various regulatory agencies in Europe, Japan, and other markets are looking into tirzepatide as a treatment for type 2 diabetes.
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