EU allows Lilly to sell its KwikPen pre-filled with tirzepatide

The European Commission (EC) has granted Eli Lilly and Company marketing authorization for the KwikPen injection device for the administration of tirzepatide (Munjaro) for two indications:

1. In adults with poorly controlled type 2 diabetes who cannot take metformin or in combination with other diabetes medications, it is always combined with diet and exercise.
2. For weight control in obese adults (BMI ≥30 kg/m2) or overweight adults (BMI ≥27 kg/m2 to

The EU’s decision to introduce KwikPen will make it easier and faster for more patients to be treated with tirzepatide. It will also allow Lilly to begin distributing the molecule in Spain in the coming months.

“We want to do everything we can to ensure our innovative medicines reach the patients who need them. This important regulatory milestone helps us move closer to this goal,” said Dr. Miriam Rubio de Santos, medical director of Lilly’s Diabetes and Obesity Division in Spain. “We recognize that there is significant unmet need and high demand for this class of new drugs, and we ask healthcare providers to ensure that all prescriptions are filled for the approved indication,” he adds.

The KwikPen is a prefilled, multi-dose pen that Lilly first brought to market in 2008. Today, it is already used to administer various diabetes medications around the world.

Tirzepatide is an agonist of the GIP (glucose-dependent insulinotropic polypeptide) receptor and the GLP-1 (glucagon-like peptide-1) receptor. It is administered once a week and has already received marketing authorization in the European Union (EU) for these two indications.

The most common side effects of tirzepatide include digestive system problems such as nausea (feeling unwell), diarrhea and constipation. They were generally mild to moderate, occurring most often during dose escalation and decreasing over time.