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The pharmaceutical company Eli Lilly and Company has received approval from the European Commission (EC) to market the KwikPen injection device to administer the drug tirzepatide (Mounjaro®). The authorization of this device by the European Commission means that treatment with tirzepatide will be more accessible to patients and will make it easier for Lilly to distribute this medicine in Spain in the coming months.
This EC authorization is limited to two specific applications:
- For adults with type 2 diabetes that is not well controlled, who cannot use metformin or who need to combine it with other diabetes treatments, always in conjunction with diet and exercise.
- In weight management for adults with obesity (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2 to <30 kg/m2) who have at least one weight-related comorbidity, accompanied by a low-calorie diet and an increase in physical activity.
“Diabetes and obesity are long-term chronic diseases with an enormous impact on people’s health and quality of life.” “Our goal is to ensure our innovative products are available to patients who need them. This important regulatory milestone helps us get closer to this goal. “We recognize that there is a significant unmet need and high demand for this class of new medicines and we ask healthcare professionals to ensure that all prescriptions are made within the framework of the authorized indication,” highlighted Dr. Miriam Rubio. de Santos, medical director of Diabetes and Obesity at Lilly Spain.
How the tirzepatide delivery device works
Tirzepatide is a novel therapeutic option in its class that acts by activating the GIP and GLP-1 hormone receptors, approved both for weight management in adults with obesity or overweight who present related comorbidities, and for the treatment of diabetes. type 2 in adults when other treatments are not appropriate.
The KwikPen is a multi-dose prefilled device, introduced by Lilly in 2008, and is used globally to administer various diabetes medications. Tirzepatide, an agonist of the GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide 1) receptors, is administered weekly and has previously been licensed in the European Union for these indications.
The most common adverse effects of tirzepatide are gastrointestinal, including nausea, diarrhea, and constipation, which are generally mild or moderate and tend to decrease over time after an initial dose titration period.
Source: Eli Lilly and Company
