Eli Lilly and Company announced that the European Commission (EC) granted marketing authorization (MA) on 19 April 2024 for tirzepatide (Mounjaro®) solution for injection in a multi-dose KwikPen® presentation, for two indications:
- 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.
- For weight management as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults
with an initial Body Mass Index (BMI) of
– ≥ 30 kg/m2 (obesity) or
– ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus).
This decision from the European Commission will enable us to bring tirzepatide to more patients, in the KwikPen presentation. “Diabetes and obesity are chronic, long-term conditions with a huge
impact on people’s health and quality of life,” said Laura Steele, President and General Manager of the UK, Ireland and Northern Europe. “We want to do everything possible to ensure our innovative medicines can reach patients who need them. This important regulatory milestone helps us to move closer to this goal.”
KwikPen is a multi-dose, pre-filled pen. First launched by Lilly in 2008, the KwikPen is already used to deliver different Lilly diabetes medicines for patients around the world. In January 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization in Great Britain for tirzepatide solution for injection in the KwikPen presentation.
About tirzepatide injection for weight management and for type 2 diabetes
Tirzepatide is a first in class, once-weekly GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) receptor agonist and has previously received marketing authorization in the European Union (EU) for type 2 diabetes and weight management.
The most common side effects with tirzepatide (which may affect more than 1 in 10 people) include problems with the digestive system, such as nausea (feeling sick) and diarrhea. Constipation and vomiting were seen in up to 1 in 10 people. Side effects linked to the digestive system were generally mild or moderate in severity and occurred more often during dose escalation and decreased over time.
Tirzepatide should only be used in accordance with the approved product information. To learn more, visit: http://www.ema.europa.eu
Tirzepatide and its delivery device base are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
