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By NS Healthcare Staff Writer  16 May 2022

Mounjaro will be offered in six doses, 2.5mg, 5mg, 7.5mg, 10mg, 12.5mg, and 15mg, together with Lilly’s auto-injector pen that comes with a pre-attached, hidden needle

Mounjaro is a GIP and GLP-1 receptor agonist. (Credit: Lilly USA, LLC.)

Eli Lilly and Company (Lilly) has obtained the US Food and Drug Administration (FDA) approval for its Mounjaro (tirzepatide) injection to treat type 2 diabetes in adults.

Mounjaro is a single molecule that activates natural incretin hormones glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist.

The drug is indicated as a once-weekly treatment, adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Lilly will offer Mounjaro, the first and only FDA approved GIP and GLP-1 receptor agonist, in six doses, including 2.5mg, 5mg, 7.5mg, 10mg, 12.5mg, and 15mg.

The company is planning to commercialise the drug in the US, together with its auto-injector pen that comes with a pre-attached hidden needle, within a few weeks

Lilly Diabetes president Mike Mason said: “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 Americans living with type 2 diabetes are not reaching their target blood glucose levels.

“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.”

The FDA approval of Mounjaro was based on results from the Phase 3 SURPASS program that started in late 2018, comprising five global trials and two regional trials in Japan.

The programme evaluated the efficacy and safety of Mounjaro 5mg, 10mg and 15mg as a monotherapy, and as an add-on to various standard-of-care medications for type 2 diabetes.

In the SURPASS programme, Mounjaro 5mg resulted in A1C reduction by 1.8% to 2.1%, and both Mounjaro 10mg and Mounjaro 15mg contributed to 1.7% and 2.4% A1C reduction.

The drug was not indicated for weight loss; however, participants treated with Mounjaro have lost 12lb (5mg) to 25lb (15mg) weight on average, said the firm.

The mean change in body weight was one of the key secondary endpoints in all SURPASS studies.

Patients treated with Mounjaro reported side effects including nausea, diarrhoea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.

Furthermore, Mounjaro comes with a Boxed Warning about thyroid C-cell tumours. The drug is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2.

Mounjaro has not been evaluated in patients with a history of pancreatitis and is not indicated for use in patients with type 1 diabetes mellitus, stated Lilly.

Post time: May-24-2022