UK's health and social care watchdog has decided against recommending Mounjaro, Eli Lilly's weight loss drug for adults with diabetes.
The National Institute for Health and Care Excellence (NICE) in the UK released draft guidance stating that they need more information about tirzepatide, the active ingredient in Mounjaro.
“Our committee can see the promise in tirzepatide, but it requires more evidence to be able to evaluate both its clinical and cost-effectiveness,” said Helen Knight, director of medicines evaluation at NICE.
Why the Need for More Evidence?The draft guidance (pdf) brought attention to the "uncertainties in the clinical evidence" provided by the manufacturer.
According to the clinical trials, tirzepatide demonstrated potential in reducing blood glucose levels and body weight when compared to semaglutide, insulin therapy, or a placebo. The company's network meta-analysis also indicated similar effects compared to all glucagon-like peptide 1 (GLP-1) receptor agonists. However, the draft said, there were uncertainties surrounding these results.
Furthermore, the draft guidance highlighted uncertainties regarding the cost-effectiveness estimates. It remained unclear how accurately the model predicted the long-term health benefits of tirzepatide compared to other GLP-1 receptor agonists (Wegovy and Ozempic) and how the company's model results aligned with other economic models for diabetes.
“Lilly is disappointed that NICE’s draft guidance does not currently recommend tirzepatide for Type 2 diabetes,” Brooke Frost, a spokesperson for Eli Lilly, told The Epoch Times via email. “Lilly’s submission to NICE was based on a new cost-effectiveness model, which has raised several technical questions from the committee. We will continue to work closely with NICE to provide further technical clarification on the model during the consultation period." There is a meeting with the Appraisal Committee scheduled for August. The final draft guidance is expected in September.
While Mounjaro has not received approval in the UK, it obtained marketing authorization in September 2022, which means the drug can now be legally marketed within the UK. The U.S. Food and Drug Administration (FDA) approved Mounjaro for treating Type 2 diabetes patients in May 2022.
Several Drugs Show Promise in Obesity Treatment
The weight loss and weight management market has reached over $200 billion globally. Numerous companies are actively developing drugs and vying for their portion of this lucrative market.
Tirzepatide was anticipated to position Eli Lilly as a leading player in the therapy for obesity and Type 2 diabetes, surpassing drugs like Ozempic and Wegovy.
Eli Lilly has completed its submission for chronic weight management and is awaiting potential FDA approval, which is expected later in 2023.
The New England Journal of Medicine (NEJM) published two phase 2 clinical trials on June 23 and June 26, both funded by Eli Lilly.
An Increasing Number of Safety ConcernsWhile most clinical trials of GLP-1-related hormone receptor agonists claimed low discontinuation rates and gastrointestinal side effects, recent safety concerns have surfaced.
On June 26, Pfizer announced that the clinical development of lotiglipron would be halted due to an increase in liver enzyme levels. Pfizer said that no liver failure or liver-related side effects were reported and that it would continue to advance danuglipron for treating obesity and Type 2 diabetes.
Both lotiglipron and danuglipron are GLP-1 agonists, with the distinction that danuglipron is taken orally twice daily, while lotiglipron is taken orally once daily.
Some doctors have raised concerns regarding the working mechanisms of these drugs, in addition to concerns about side effects. Since they primarily suppress appetite rather than promote fat burning, there is a potential risk of muscle loss, leading to additional health problems.