European Commission authorizes Mounjaro for type 2 diabetes across the EU
The EU cleared tirzepatide for type 2 diabetes in all member states, adding a once-weekly option in the same drug family as semaglutide, though the decision does not change US access.
Mounjaro (tirzepatide) received a marketing authorization valid throughout the European Union on September 15, 2022, for the treatment of type 2 diabetes [1]. The decision was issued by the European Commission after review by the European Medicines Agency, and the authorization is held by Eli Lilly Nederland B.V. [1]. The medicine is available only by prescription as a once-weekly injection given under the skin of the abdomen, thigh or upper arm [1].
Mounjaro contains tirzepatide, which acts on two gut hormone targets, GLP-1 and GIP [1]. That makes it a different molecule from semaglutide, the active substance in Ozempic, Wegovy and Rybelsus [1]. The agency based its decision on five main studies involving more than 6,000 adults with type 2 diabetes [1].
In two of those studies, Mounjaro lowered HbA1c — the share of hemoglobin carrying glucose — by up to 2.1 and 2.6 percentage points after 40 weeks, compared with no decrease and a 0.9 percentage point decrease in people given a placebo [1]. In a third study, adding it to metformin lowered HbA1c by up to 2.5 percentage points after 40 weeks, against 1.9 percentage points for semaglutide [1]. A fourth study reported up to 2.4 percentage points after 52 weeks compared with 1.3 points for insulin degludec, and a fifth up to 2.6 points after 52 weeks compared with 1.4 points for insulin glargine [1].
A separate study of 99 adolescents aged 10 to under 18 found Mounjaro lowered HbA1c by about 2 percentage points after 30 weeks, compared with 0.2 points with placebo [1]. The EU label covers patients aged 10 and older with type 2 diabetes that is not well controlled, used alone when metformin is not suitable or added to other diabetes medicines [1].
The label now also covers weight management in adults with a BMI of 30 or higher, or 27 to 30 with at least one weight-related condition such as high blood pressure, abnormal blood fats or obstructive sleep apnea [1]. In a study of more than 2,500 adults with obesity or excess weight, participants who took Mounjaro along with diet and exercise for 72 weeks lost at least 15% of their body weight on average, depending on dose, compared with 3% for placebo; more than 85% lost at least 5%, compared with 35% on placebo [1]. The date that weight-management use was added to the EU authorization has not been reported.
The most common side effects, affecting more than 1 in 10 people, include nausea, vomiting, abdominal pain, constipation and diarrhea, plus low blood sugar when the medicine is used with a sulfonylurea or insulin [1]. The agency said the benefits of Mounjaro outweighed its risks [1].
Why it matters for patients
For people in the United States, this decision changes nothing directly. It applies to the European Union and does not address US availability, US labeling or insurance coverage; those details are not part of the EU assessment record [1].
What the decision does show is the evidence European regulators weighed before clearing another drug in the same hormone family as semaglutide for type 2 diabetes — a once-weekly injection that lowered HbA1c in five studies and produced average weight loss of at least 15% over 72 weeks in adults with obesity or excess weight [1]. The weight-management use described in the EU label is limited to adults who meet specific BMI thresholds [1]. The two molecules are not interchangeable, and one of the trials compared them head to head [1].
What happens next
The European Medicines Agency says data on the use of Mounjaro are continuously monitored, suspected side effects are evaluated, and any necessary action is taken to protect patients [1]. Any future change to the EU label, including new uses or new warnings, would appear in the same public assessment record. No dates for further EU decisions on Mounjaro have been disclosed.
Sources
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