European Commission grants marketing authorisation for Lilly’s Mounjaro® (tirzepatide), the first GIP and GLP-1 receptor agonist for adults with type 2 diabetes in Europe
Eli Lilly and Company announced today that the European Commission has granted marketing 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 for the treatment of adults with insufficiently controlled type 2 diabetes mellitus. The decision follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use’s (CHMP) positive opinion issued in July 2022.
As the first GIP and GLP-1 receptor agonist approved by the European Commission, tirzepatide is a single molecule that activates the body’s receptors for GIP and GLP-1, which are natural incretin hormones responsible for regulating blood glucose levels in response to eating food.
The decision is based on data from the SURPASS phase 3 global clinical development program, which included placebo and active comparators of injectable semaglutide 1 mg, insulin glargine and insulin degludec. Efficacy was evaluated for tirzepatide5 mg, 10 mg and 15 mg used alone or in combination with commonly prescribed diabetes medications, including metformin, SGLT2 inhibitors, sulphonylureas and insulin glargine. Participants in the SURPASS program achieved average A1C reductions between 1.87% and 2.24% for tirzepatide5 mg, between 1.89% and 2.59% for tirzepatide10 mg and between 2.07% and 2.59% for tirzepatide15 mg.
The most frequently reported adverse reactions were gastrointestinal disorders, including nausea, diarrhoea and vomiting. In general, these reactions were mostly mild or moderate in severity and occurred more often during dose escalation and decreased over time.
Tirzepatide will be available in six doses (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg).
Lilly unites caring with discovery to create medicines that make life better for people around the world. We’ve been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 47 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world’s most significant health challenges, redefining diabetes care, treating obesity and curtailing its most devastating long-term effects, advancing the fight against Alzheimer’s disease, providing solutions to some of the most debilitating immune system disorders, and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we’re motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable.
Tags in this Article:
Lilly Receives EU Marketing Authorisation for Retsevmo® as a First-Line Treatment for...
Eli Lilly and Company today announced that the European Medicines Agency (EMA) has granted marketing authorisation (MA) for Retsevmo® (selpercatinib 40 mg & 80 mg oral capsules) as a first-line monotherapy indicated for the treatment of adults and adolescents 12 years and older with advanced RET-mutant medullary thyroid cancer.
CHMP Recommends Approval of Lilly’s Mounjaro™ (tirzepatide), the first GIP and GLP-1...
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.
The research-based pharmaceutical industry has a vision for a healthier future for At...
Across Europe there is a stark variation in speed of access to new medicines for patients in different countries. Today, patients in Germany are able to access new medicines in 133 days after they have been approved by the European Medicines Agency, while patients in Romania have to wait an average of 899 days.