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The U.S. Food and Drug Administration (FDA) and the Medicines and Healthcare products Regulatory Agency have approved Eli Lilly and Company's Zepbound (Mounjaro) (tirzepatide) injection, the first and only obesity treatment of its kind that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors.
Zepbound (Mounjaro) is indicated for adults with obesity or those who are overweight and also have weight-related medical problems such as hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea or cardiovascular disease, to lose weight and keep it off. The drug should be used with a reduced-calorie diet and increased physical activity.
Zepbound should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines, and it has not been studied in patients with a history of pancreatitis, or with severe gastrointestinal disease, including severe gastroparesis.
"Obesity is a chronic disease that can result in serious health complications, including heart disease, stroke and diabetes. Despite our knowledge of obesity as a treatable, chronic disease, people living with obesity still face many challenges in their health and weight management journey," said Joe Nadglowski, president and chief executive officer of the Obesity Action Coalition. "New treatment options bring hope to the many people with obesity who struggle with this disease and are seeking better options for weight management."
This recent announcement means that access to revolutionary weight-loss drugs will, to a certain extent, be far greater. Novo Nordisk's Wegovy has dominated the weight-loss market despite various issues and alleged concerns surrounding the price of the drug and some of the unpleasant side-effects.
Zepbound will cost a significant $1,059.87 a month - roughly £863.50 - according to Lilly. Nonetheless, for the price of $1,349 (£1099.06) per-package for Novo Nordisk's Wegovy.
The most common side effects of the medicine are nausea, diarrhoea, vomiting (which usually goes away over time), and constipation. Low blood sugar (hypoglycaemia) is also very common in patients with diabetes. Symptoms of this can include headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, fast heartbeat and sweating.
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said: We have prioritised rapid assessment of this new indication for Mounjaro, given the public health importance of access to new medicines to help tackle obesity. We have drawn on advice from the independent Commission on Human Medicines in coming to our decision, and as with all products, will keep the safety of Mounjaro under close review.
The new weight management indication is based on the results of two international, randomised double-blind, placebo-controlled clinical trials, SURMOUNT-1 and SURMOUNT-2, in overweight and obese adult patients with and without diabetes. The studies showed that patients who were treated with tirzepatide had a significant weight loss over time compared to patients who took a placebo.
Given Novo Nordisk became one of the most valuable companies in Europe in large-part due to the success of Wegovy's release, culminating in an increase in share prices, the Danish Company may be less than pleased that their unrivalled position will be destabilised. Yet, for people who desperately need these drugs, a cheaper yet seemingly just as effective alternative will be welcome.