CHMP Recommends Approval of Lilly’s Mounjaro™ (tirzepatide), the first GIP and GLP-1 receptor agonist for adults with type 2 diabetes
Eli Lilly and Company announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion and recommended the authorisation for the use of Mounjaro™ (tirzepatide), a once-weekly GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) receptor agonist, as an adjunct to diet and exercise in adults with insufficiently controlled type 2 diabetes. Tirzepatide solution for injection activates the body’s receptors for GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1), which are natural incretin hormones responsible for regulating blood glucose levels in response to eating food.
This is an important regulatory step toward European approval of tirzepatide for adults with type 2 diabetes. The CHMP positive opinion is now referred to the European Commission for final action. If approved, tirzepatide will be the first GIP and GLP-1 receptor agonist available for people with type 2 diabetes in Europe. The European Commission’s decision on marketing authorisation is expected in the next two months.
The CHMP positive opinion is based on data from the SURPASS phase 3 global clinical development programme, which included placebo and active comparators of injectable semaglutide 1 mg, insulin glargine and insulin degludec. Efficacy was evaluated for tirzepatide 5 mg, 10 mg and 15 mg used alone or in combination with commonly prescribed diabetes medications, including metformin, SGLT2 inhibitors, sulphonylureasand insulin glargine. Participants in the SURPASS program achieved average A1C reductions between 1.87% and 2.24% for tirzepatide 5 mg, between 1.89% and 2.59% for tirzepatide 10 mg and between 2.07% and 2.59% for tirzepatide 15 mg. While not indicated for weight loss, mean change in body weight was a key secondary endpoint in all SURPASS studies. Participants treated with tirzepatide lost between 6.2 kg and 7.8 kg with tirzepatide 5 mg, between 7.8 kg and 10.7 kg with tirzepatide 10 mg and between 9.5 kg and 12.9 kg with tirzepatide 15 mg.
The most common side effects are hypoglycaemia when used in combination with sulphonylurea or insulin, and gastrointestinal side effects such as nausea and diarrhoea. In general, these reactions were mostly mild or moderate in severity and occurred more often during dose escalation and decreased over time.
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