Mounjaro, a new injectable drug from Eli Lilly and Company, has received the approval of the UK’s healthcare cost-effectiveness watchdog, NICE, as a treatment for adults with type 2 diabetes. The drug, also known as tirzepatide, is the first and only GIP and GLP-1 receptor agonist approved in the UK, meaning that it activates two natural hormones that regulate blood sugar levels.
Mounjaro is expected to be a good option for patients with poorly controlled type 2 diabetes who have not responded well to other medications. According to NICE, about 180,000 people in the UK could benefit from the new treatment. The drug will be available in the UK’s National Health Service (NHS) within 90 days after the final guidance from NICE is published on Oct. 11.
Superior and consistent results in clinical trials
The approval of Mounjaro was based on the results from the phase 3 SURPASS program, which included active comparators of injectable semaglutide 1 mg, insulin glargine and insulin degludec. Mounjaro was evaluated in six doses (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg) used alone or in combination with commonly prescribed diabetes medications, such as metformin, SGLT2 inhibitors, sulfonylureas and insulin glargine.
In the clinical trials, Mounjaro delivered superior and consistent A1C reductions versus all comparators. A1C is a measure of average blood sugar levels over a period of three months. Participants in the SURPASS program achieved average A1C reductions between 1.8% and 2.1% for Mounjaro 5 mg and between 1.7% and 2.4% for both Mounjaro 10 mg and Mounjaro 15 mg.
While not indicated for weight loss, Mounjaro also led to significantly greater weight reductions versus comparators in a key secondary endpoint. Participants treated with Mounjaro lost between 12 lb. (5 mg) and 25 lb. (15 mg) on average. Weight loss can be beneficial for people with type 2 diabetes as it can improve blood sugar control and reduce the risk of complications.
A potential game-changer for obesity
Mounjaro is not only a breakthrough treatment for type 2 diabetes, but also a potential game-changer for obesity. The drug has shown striking results in helping obese or overweight people without diabetes lose up to almost a quarter of their body weight, or 22%, after 17 months compared to a 2% weight loss with a placebo. These are the kinds of results that doctors see with gastric bypass surgery.
Lilly is seeking FDA approval for Mounjaro as an obesity treatment and expects a decision later this year. If approved, Mounjaro could become the best-selling drug of all time, as obesity affects more than 650 million people worldwide and is associated with increased risk of cardiovascular disease, cancer and mortality.
Mounjaro will face competition from Novo Nordisk A/S, another leader in the diabetes and obesity market. Novo has already launched Wegovy, a version of its diabetes drug Ozempic approved for weight loss by the FDA. Wegovy helped patients lose an average of 12% of their initial body weight after 16 months compared to those who received placebo. Novo is also developing a dual-acting competitor to Mounjaro, but it is still in early-stage testing.
