European regulators recommend Mounjaro (tirzepatide) for type 2 diabetes

The European Medicines Agency's main medicines committee has recommended approving Mounjaro (tirzepatide) for type 2 diabetes, moving the drug toward authorization across the European Union ^[1]. The Committee for Medicinal Products for Human Use adopted its positive opinion on July 21, 2022, and the European Commission granted the EU-wide marketing authorization on September 15, 2022 ^[1].

Mounjaro is a prescription medicine given as a once-weekly injection under the skin of the abdomen, thigh or upper arm ^[1]. It is used alongside diet and physical activity to treat adults, adolescents and children aged 10 and older whose type 2 diabetes is not satisfactorily controlled, either on its own for patients who cannot take metformin or as an add-on to other diabetes medicines ^[1]. The active substance, tirzepatide, acts like two hormones the body makes in the gut, GLP-1 and GIP, which increases insulin release after food, lowers blood glucose and reduces appetite ^[1].

What the studies showed

The agency reviewed five main studies of Mounjaro in more than 6,000 adults with type 2 diabetes, measuring HbA1c, a marker of average blood sugar control ^[1].

In two of those studies, Mounjaro lowered HbA1c by up to 2.1 and 2.6 percentage points after 40 weeks — when added to lifestyle changes alone, or to insulin glargine with or without metformin. Those results compared with no decrease, or a decrease of 0.9 percentage points, in people who received a placebo ^[1].

A third study found a reduction of up to 2.5 percentage points after 40 weeks when Mounjaro was added to metformin, compared with a 1.9-percentage-point drop in patients taking semaglutide, another diabetes medicine ^[1]. A fourth study reported a drop of up to 2.4 percentage points after 52 weeks alongside metformin with or without an SGLT2 inhibitor, versus 1.3 points with insulin degludec, and a fifth reported up to 2.6 points after 52 weeks alongside up to three oral medicines, versus 1.4 points with insulin glargine ^[1].

A separate study of 99 adolescents aged 10 to under 18 found HbA1c fell by around 2 percentage points after 30 weeks, compared with 0.2 points in those given a placebo ^[1].

The same EU authorization covers weight management in adults who have obesity, defined as a BMI of 30 or higher, or who are overweight with a BMI between 27 and 30 plus a weight-related health problem such as diabetes, high blood fat, high blood pressure or obstructive sleep apnoea ^[1]. In a study of more than 2,500 such participants, those using Mounjaro with diet and exercise for 72 weeks lost at least 15 percent of their body weight on average, depending on dose, compared with 3 percent for placebo; more than 85 percent of those taking Mounjaro lost at least 5 percent of their weight, compared with 35 percent of those taking placebo ^[1].

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 drug is used with a sulfonylurea or insulin ^[1]. The agency described these as generally mild or moderate and more frequent shortly after a dose increase ^[1].

Why it matters for patients

This is a European regulatory decision. It does not change whether Mounjaro is available in the United States, what it costs there, or whether US insurers cover it; the EMA material does not address US availability or coverage, and those details have not been reported here ^[1].

The opinion adds tirzepatide to the injectable options European regulators consider appropriate for type 2 diabetes, including for children as young as 10, a group with fewer approved treatments ^[1]. The figures above are described by the regulator as upper-end or average results in trials that enrolled specific groups of patients, not a prediction of what any one person will experience ^[1].

One of the reviewed trials compared tirzepatide with semaglutide directly; the others used placebo, insulin glargine or insulin degludec as comparators ^[1]. Whether the two drugs differ in real-world results outside those trial settings has not been established by the documents reviewed.

What happens next

With the committee opinion issued, the European Commission issued the formal marketing authorization on September 15, 2022, making Mounjaro valid for use throughout the EU ^[1]. The EMA says data on the medicine's use are monitored continuously, with reported side effects evaluated and action taken if needed ^[1]. No timeline for any further label changes was disclosed ^[1].