The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Eli Lilly’s tirzepatide solution for injection in an alternative KwikPen presentation, for two indications:
For the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:
as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
in addition to other medicinal products for the treatment of diabetes.
2. For weight management, including weight loss and weight maintenance, as an adjunct to a reduced-calorie diet and increased physical activity in 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).
“The MHRA is the first major regulator in the world to issue marketing authorisation for the alternative KwikPen presentation for tirzepatide, demonstrating their clear focus on speeding innovation to help patients. This will enable Lilly to begin supply to the UK within weeks,” said Laura Steele, President and General Manager of UK and Northern Europe at Lilly. “Diabetes and obesity are chronic, long-term conditions with a huge impact on people’s health and quality of life, and Lilly is deeply committed to making people’s lives better in these areas. We recognise there is significant unmet need and also high demand for this class of new medicines – we ask healthcare professionals to ensure all prescribing is within the authorised indications.”
Tirzepatide is a once-weekly GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) receptor agonist and has previously received marketing authorisation in the UK for these two indications in different presentations.
The most common side effects of the medicine are nausea, diarrhoea, vomiting and constipation. Low blood sugar (hypoglycaemia) is also very common in patients with diabetes when used with sulphonylurea or insulin. Symptoms of this can include headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, fast heartbeat and sweating.
"The public health importance of safe and effective treatments to help manage diabetes and obesity, which can have a significant impact on people's health, is clear,” said Julian Beach, MHRA interim executive director of healthcare quality and access. “This approval enables access to the approved Mounjaro pen in a more convenient presentation of a month's treatment, of one dose per week."
Women with obesity or overweight using oral contraceptives should consider also using a barrier method of contraception (e.g., a condom) or switching to a non-oral contraceptive method for 4 weeks after starting tirzepatide and for 4 weeks after each increase in dose.
The MHRA said it will keep the safety and effectiveness of Mounjaro under close review.