AstraZeneca's Triple-Combination Antidiabetic Drug Qtrilmet (Metformin/Saxagliptin/Dapagliflozin) Receives Positive CHMP Opinion for EU Approval
Sep 23, 2019 16:38
CST Updated
16:38
AstraZeneca
Biopharmaceutical Manufacturer
European Medicines Agency
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.
September 23, 2019/BioValleyBIOON/--AstraZeneca(AstraZeneca) recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending approval of Qtrilmet (metformin hydrochloride, saxagliptin, dapagliflozin) modified-release tablets for type 2DiabetesTreatment of Adult Patients.
Qtrilmet is a triple-combination tablet for once-daily oral administration, composed of the selective sodium-glucose cotransporter 2 (SGLT2) inhibitor Forxiga (dapagliflozin), the dipeptidyl peptidase-4 (DPP-4) inhibitor Onglyza (saxagliptin), and extended-release metformin hydrochloride.
In the United States, Qtrilmet was approved in May this yearFDAApproved for marketing under the brand name Qternmet XR, as an adjunct to diet and exercise, to improve type 2DiabetesGlycemic Control in Adult Patients.
Specifically, the CHMP recommended approval of Qtrilmet for: (1) type 2 diabetes when metformin (with or without SU) in combination with saxagliptin or dapagliflozin does not provide adequate glycemic controlDiabetesAdult patients; (2) with type 2 diabetes already receiving combination therapy with metformin, saxagliptin, and dapagliflozinDiabetesAdult patients.
The CHMP’s positive opinion is based on data from five Phase III clinical studies. These studies evaluated the combination therapy of Farxiga and Onglyza with background metformin in adult patients with type 2 diabetes whose blood glucose was not adequately controlled. The primary endpoint of these studies was the mean change in HbA1c (average blood glucose level) from baseline at Week 24 or Week 52.
The results showed that in the aforementioned clinical studies, the combination of Forxiga + Onglyza + metformin was superior to Forxiga + metformin, Onglyza + metformin, and glimepiride + metformin in reducing HbA1c levels. The combination of Forxiga + Onglyza + metformin (with or without sulfonylureas [SU]) demonstrated non-inferior efficacy in reducing HbA1c compared to the combination of insulin + metformin (with or without SU). In these studies, the safety profile of each drug was consistent with its known safety characteristics. (Bioon.com)