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Eli Lilly’s Diabetes Drug Mounjaro Approved

Mounjaro

Eli Lilly’s diabetes drug Mounjaro has gained the backing of Britain’s healthcare cost-effectiveness watchdog, which said it would be a good option for patients with poorly controlled type 2 diabetes. The National Institute for Health and Care Excellence (NICE) said in draft final guidance that it estimates some 180,000 people could benefit from the new treatment.

Lilly’s Commitment to Diabetes

Eli Lilly regards itself as a global leader in diabetes care; in 1923, it introduced the world’s first commercial insulin as researchers from the University of Toronto made a scientific breakthrough that transformed the treatment of diabetes. Since then, diabetes treatment has come a long way with innovations such as infusion pumps, auto-injectors, continuous glucose monitoring and data management apps.

As a consequence of the approval, Eli Lilly’s share price has surged, with investors betting that the approval will make it a blockbuster drug. Final guidance from NICE, the government agency that determines if medicines should be used in the NHS, is scheduled to be published in a month’s time after which the drug will be made available in the UK’s National Health Service (NHS) within 90 days.

This also follows Lilly’s experimental drug, donanemab, for Alzheimer’s.

Mounjaro’s approval

Mounjaro is expected to be about 20% more effective than Ozempic to treat Type 2 diabetes. Its approval could see 180,000 people with diabetes being treated as a once-weekly injection. This injection, instead of targeting one receptor to produce insulin like existing medications, is the first to target two receptors to promote the secretion of insulin. In studies, the drug reduced average blood sugar levels to within a normal range in 81 to 97 per cent of people, which NICE said “was statistically significantly more than with any comparator”.

In one trial, published in the New England Journal of Medicine, 51 per cent of those taking Mounjaro lowered their blood sugar levels to a threshold seen in people without diabetes, compared with 20 per cent of those taking semaglutide.

The new drug also works as a weight-loss jab and is recommended to help patients with Type 2 diabetes lose weight, if they have an obesity-related condition such as high blood pressure, as well as either a body mass index (BMI) of more than 35 or if they are unable to use insulin injections. Trials have shown the drug could reduce body weight by as much as 26 per cent, significantly more than the around 15% expected from Novo Nordisk’s Wegovy.

The decision to approve the drug comes amid national shortages of Novo Nordisk’s Ozempic, which is from the same drug class as Mounjaro and is approved in Britain for treatment of type 2 diabetes. Advocacy group Diabetes UK told Reuters this week that Ozempic’s increasing “off-label” use for weight-loss has hurt people with type 2 diabetes who have been prescribed the drug but have struggled to fill their prescriptions.

Approximately 4.5 million people in the UK have Type 2 diabetes. A number of them have been affected by shortages of GLP1 medication, which includes semaglutide, and forced to move on to alternatives or insulin.

Responses

Douglas Twenefour, head of care at Diabetes UK, said current medication shortages were “causing stress and uncertainty for many people with Type 2 diabetes. “Whilst the approval of tirzepatide is welcome, we are calling for more action to ensure ongoing and sufficient supply of these medications to people with Type 2 diabetes.”

The drug will only be available to patients who have not been able to get their diabetes under control with oral antidiabetic drugs, although it has been approved for wider groups of patients in other countries.

Helen Knight, director of medicines evaluation at Nice, said: “There are very few new medicines being developed to treat difficult to manage Type 2 diabetes. Our committee recognised the potential tirzepatide has to provide an effective and good value treatment option for all those living with poorly controlled Type 2 diabetes.”

David Webb, Chief Pharmaceutical Officer at NHS England, said the announcement was “great news … at a time when there is disruption to the supply of key drugs used for treating people with diabetes”.

He added: “This will provide a much-needed addition to other available treatments, and can be prescribed alongside diet and exercise.”

Curia’s NHS and Life Sciences Commission

Following the successful launch of the NHS Innovation and Life Sciences Commission’s 2022 Report, the Commission will appraise the outlined recommendations in 2023. This will allow a measurement of success to be taken on each implementation and a review of new priorities for the NHS and life sciences industry. The Commission will continue to review case studies to highlight best practice for the 2022 recommendations. Through a series of sprints, the Commission will highlight real-world experiences in regions across the UK. Through targeted health data mapping, relevant areas of unmet need and health inequalities can be chosen. Each sprint may appraise one or multiple topic areas from the 2022 report.

The Commission will also hold dedicated inquiry sessions into specific system-level and therapeutic areas of focus. Using the same methodology, the inquiries will provide opportunities for the Commission to gain implementable solutions to these areas and develop similar policy recommendations and reports.

The Commission will continue periodic consultation with selected advisory group bodies and sponsors to steer the methodology and direction of the 2023 activities.

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