A new weight loss drug will come to the United Kingdom within weeks to treat thousands of patients with type 2 diabetes or obesity after successfully pre-filling it into an injection pen.
Mounjaro drug was developed by Eli Lilly, a US pharmaceutical company. The drug can be inserted under the skin of a patient's stomach area, thigh, or upper arm.
Mounjaro, known as tirzepatide, was approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) late last year to treat obesity and type 2 diabetes. The drug should be taken together with a reduced-calorie diet and increased physical activity.
The MHRA has approved a new device for delivering the drug, a four-dose pen branded as KwikPen, to be available within weeks. On Thursday, the MHRA announced that there would be an alternative to the weight-loss drug Wegovy, also known as semaglutide, manufactured by the Danish company Novo Nordisk.
The National Institute for Health and Care Excellence also authorized the drug for use in the NHS for type 2 diabetes and is awaiting approval for obesity.
President and general manager of UK and Northern Europe at Lilly, Laura Steele, claimed that the MHRA is the first major regulator in the world to issue marketing authorization for the alternative KwikPen presentation for tirzepatide, demonstrating their clear focus on speeding innovation to help patients.
Furthermore, Julian Beach, the MHRA's healthcare quality and access interim executive director, said, "The public health importance of safe and effective treatments to help manage diabetes and obesity is clear. This approval enables access to the approved Mounjaro pen of a month's treatment, of one dose per week."
MHRA Confirms Mounjaro's Effective Treatment
The MHRA's newest authorization is based on the findings of a bridging study, which indicated that the multidose Mounjaro KwikPen's safety and efficacy are anticipated to be equivalent to those of the single-dose pen.
Douglas Twenefour, head of care at Diabetes UK, said that they hope the MHRA's approval of KwikPen will help people living with type 2 diabetes access this effective treatment.
He continued that supporting people with type 2 diabetes to lose weight and manage their blood sugar levels is critical to reducing the risk of diabetes-related complications. He noted that Mounjaro expands the range of treatment options available to help people achieve effective treatment.
However, the MHRA warned that the drug may impact obese or overweight female patients' ability to use the contraceptive pill effectively. It also mentioned several possible side effects of the drug, such as constipation, nausea, vomiting, and diarrhea.
The MHRA ensured it would continue closely monitoring Mounjaro's efficacy and safety.
