CHMP adopts a positive opinion on Mounjaro

On July 21, 2022, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending that tirzepatide, sold as Mounjaro, be authorized in the European Union to treat adults, and later adolescents aged 10 and older, with type 2 diabetes that is not well controlled ^[1]. A positive CHMP opinion is a recommendation; the European Commission still had to issue a formal decision, which it did on September 15, 2022, granting Mounjaro an EU-wide marketing authorization ^[1].

The recommendation rested on five main studies involving more than 6,000 adults with type 2 diabetes ^[1]. In one trial, Mounjaro lowered HbA1c, a measure of average blood glucose, by up to 2.1 percentage points after 40 weeks when added to lifestyle changes alone, versus no decrease with placebo ^[1]. In a head-to-head comparison against semaglutide, another GLP-1 medicine, Mounjaro reduced HbA1c by up to 2.5 percentage points after 40 weeks when added to metformin, compared with a 1.9 point drop for patients on semaglutide ^[1]. Against insulin degludec and insulin glargine in separate studies, Mounjaro produced larger HbA1c reductions as well, up to 2.4 and 2.6 percentage points respectively ^[1]. A smaller 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 on placebo ^[1].

A separate weight-management study in more than 2,500 adults with obesity or who were overweight with a related health problem found that people taking Mounjaro alongside diet and exercise for 72 weeks lost at least 15% of their body weight on average, depending on dose, compared with 3% for placebo ^[1]. More than 85% of those on Mounjaro lost at least 5% of their weight, versus 35% on placebo ^[1].

The most common side effects, reported in more than 1 in 10 patients, were low blood glucose when Mounjaro was combined with a sulphonylurea or insulin, along with nausea, vomiting, abdominal pain, constipation and diarrhea ^[1]. The EMA said these gut-related effects were generally mild to moderate and more common shortly after a dose increase, and it judged Mounjaro's benefits to outweigh its risks ^[1].

Why it matters for patients

This action applies to the European Union, not the United States, so it does not by itself change what is available or covered here. Mounjaro had already gone through separate review in the US before this EU step. What this development adds is a fuller public accounting of the trial data European regulators used, including the direct comparison against semaglutide and against two long-acting insulins, which can help patients and clinicians weigh how tirzepatide's blood sugar effects compare with other options they may already know ^[1].

The EMA overview also draws a distinction worth noting: tirzepatide acts on two gut hormone receptors, GLP-1 and GIP, while semaglutide-based products like Ozempic act on GLP-1 alone ^[1]. Readers comparing Mounjaro with Ozempic, Wegovy, or Rybelsus should keep in mind these are different molecules with different receptor targets, even though all are used for blood sugar or weight control ^[1].

What happens next

The CHMP's July 21, 2022 opinion was a recommendation, not a final authorization ^[1]. The European Commission converted that recommendation into a binding, EU-wide marketing authorization on September 15, 2022 ^[1]. The EMA has said it will continue to monitor safety data as Mounjaro use expands, and any newly identified risks will be evaluated and acted on as needed ^[1].