Tirzepatide authorised by MHRA for weight management in UK

Eli Lilly and Company has announced today that the MHRA has granted marketing authorisation for tirzepatide for weight management.

The once-weekly GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) receptor agonist can now be used for weight loss and weight maintenance, as an adjunct to a reduced-calorie diet and increased physical activity.

This applies to adults with an initial BMI of:

• ≥ 30 kg/m² (obesity) or
• ≥ 27 kg/m² to < 30kg/m² (overweight) in the presence of at least one weight-related co-morbidity (e.g. hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes).

Tirzepatide is the first GIP and GLP-1 receptor agonist to receive MHRA marketing authorisation for weight management in adults in the UK.

Tirzepatide currently has marketing authorisation in Great Britain for the treatment of adults with insufficiently controlled type 2 diabetes as an adjunct to diet and exercise.

Professor Rachel Batterham, Senior Vice President for International Medical Affairs at Lilly, said: “Obesity is a complex, chronic disease that significantly negatively impacts people’s health, quality of life and life expectancy.

“Tackling obesity requires a holistic approach including prevention strategies, and for those already affected by obesity, clinical services and effective treatment options.”

She added: “We’re delighted that tirzepatide has been authorised in Great Britain. Tirzepatide is a new class of medication that can offer eligible people living with obesity another treatment option and potentially reduce the economic impact of obesity, which is estimated to cost the NHS £6.1 billion annually.”

Fernando Campo, Associate Vice President – Head of Diabetes & Obesity, Lilly Northern Europe, said: “Lilly believes that, just like any other disease, managing obesity requires comprehensive care.

“Before launching a new treatment, we need to ensure that we can appropriately supply the medicine. We are continuing to work closely with relevant government agencies to enable access to tirzepatide as soon as possible.”

This authorisation is based on results from the phase 3 SURMOUNT-1 and SURMOUNT-2 clinical trials, which both met their co-primary endpoints of demonstrating that tirzepatide 10mg and 15mg achieved superior mean percent change in body weight from baseline and greater percentage of participants achieving body weight reductions of at least five per cent compared to placebo.

SURMOUNT-1 studied adults with obesity or overweight without diabetes and included a total of 2539 participants. SURMOUNT-2 evaluated adults with obesity or overweight and type 2 diabetes and included a total of 938 participants.

All participants treated with tirzepatide started the study at a dose of 2.5 mg once-weekly for four weeks.

Then the dose of tirzepatide was increased by 2.5 mg every four weeks until they reached their assigned dose.

In SURMOUNT-1 the dose of tirzepatide or matching placebo was escalated to five mg, 10 mg, or 15 mg subcutaneously once-weekly during a 20-week period followed by the maintenance period. In SURMOUNT-2, the dose of tirzepatide or matching placebo was escalated to 10 mg or 15 mg subcutaneously once-weekly during a 20-week period followed by the maintenance period.

In SURMOUNT-1, participants taking tirzepatide achieved average weight reductions of 16 per cent (16.1 kg) on five mg once-weekly, 21.4 per cent (22.2 kg) on 10 mg once-weekly and 22.5 per cent (23.6 kg) on 15 mg once-weekly, compared to placebo (2.4 per cent, 2.4 kg). Additionally, 89.4 per cent (5 mg), 96.2 per cent (10 mg) and 96.3 per cent (15 mg) of people taking tirzepatide achieved at least five per cent body weight reduction compared to 27.9 per cent of those taking placebo.

In SURMOUNT-2, participants taking tirzepatide achieved average weight reductions of 13.4 per cent (13.5 kg) on 10 mg once-weekly and 15.7 per cent (15.6 kg) on 15 mg once-weekly compared to placebo (3.3 per cent, 3.2 kg).

Additionally, 81.6 per cent (10 mg) and 86.4 per cent (15 mg) of people taking tirzepatide achieved at least five per cent body weight reduction compared to 30.6 per cent of those taking placebo.

The overall safety profile of tirzepatide was consistent with previously reported SURPASS trials (SURPASS 1-5 were five global randomised, controlled, phase 3 studies evaluating the safety and efficacy of tirzepatide in people with type 2 diabetes) and similar to other incretin-based therapies for the treatment of obesity.

The most commonly reported adverse events were nausea, diarrhoea, vomiting and constipation and were generally mild to moderate in severity, usually occurring during the dose-escalation period.