Lilly Receives European Marketing Authorization for tirzepatide (Mounjaro®) in KwikPen® Presentation for Two Indications
Brussels, April, 24 2024 – 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 to be used alone for patients who cannot take metformin or in addition to other medicinal products for the treatment of diabetes as an adjunct to diet and exercise.
For weight management in adults with BMI ≥30 kg/m2, or overweight (BMI ≥27 kg/m2 to <30 kg/m2) with at least one weight-related comorbidity, alongside a reduced calorie diet and increased physical activity.
This decision from the European Commission will enable us to bring tirzepatide to more patients, more quickly, in the KwikPen presentation. This will enable Lilly to begin supply to across different countries in Europe “Diabetes and obesity are chronic, long-term conditions with a huge impact on people’s health and quality of life. 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. We recognise there is significant unmet need and high demand for this class of new medicines and ask healthcare professionals to ensure all prescribing is within the authorised indication.”
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.
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 authorization in the European Union (E.U.) for these two indications.
About tirzepatide (Mounjaro®) injection for weight management and injection for type 2 diabetes Tirzepatide (Mounjaro®) is approved for treatment of weight management in adults with BMI ≥30 kg/m2), or overweight (BMI ≥27 kg/m2 to <30 kg/m2) with at least one weight-related comorbidity, alongside a reduced calorie diet and increased physical activity. It is also approved for the treatment of adults with insufficiently controlled type 2 diabetes to be used alone for patients who cannot take metformin or in addition to other medicinal products for the treatment of diabetes.
Tirzepatide is the first-of-its kind therapeutic option that works differently by activating both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide 1) hormone receptors.
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 (Mounjaro®) should only be used in accordance with the approved product information. To learn more, visit: http://www.ema.europa.eu
Tirzepatide (Mounjaro®) and its delivery device base are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. Learn more at https://www.lilly.com/eu/
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