Eli Lilly has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has become the first major regulator to issue marketing authorisation for tirzepatide solution for injection in an alternative KwikPen presentation. It will be available through prescription in Great Britain for two indications:
- For the treatment of adults with insufficiently controlled type 2 diabetes 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.
- 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 <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity (e.g. hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes or type 2 diabetes).
Tirzepatide (sold as Mounjaro) is a once-weekly GIP analogue combined with a GLP-1 analogue. It works by activating both GIP and GLP-1 receptors to promote the secretion of incretin hormones that increase the production of insulin and decrease the glucose produced by the liver, lowering blood glucose.
It has previously received marketing authorisation for these indications in different presentations. The Mounjaro KwikPen will, however, deliver four doses, rather than the one dose from the previously approved Mounjaro pen. It is hoped that presenting a month’s treatment in one pen will allow for convenient use.
The most common side effects are nausea, diarrhoea, vomiting and constipation. Hypoglycaemia is very common in people with diabetes when used with a sulfonylurea or insulin. Women with obesity or overweight using oral contraceptives should consider also using a barrier method of contraception or switching to a non-oral contraceptive method.
With nearly one in three adults being obese, demand for the drug is expected to be high. When supplies become available in the coming weeks, healthcare professionals are being asked to ensure that all prescribing is within the authorised indications.
