The US Food and Drug Administration (FDA) may have favored the generic version of Crestor, the cholesterol-lowering drug of AstraZeneca plc (NYSE:AZN), but the company has won the approval of the European Commission for Type 2 diabetes drug, Qtern.
Qtern is a combination of dapagliflozin and saxagliptin, which are approved as Farxiga and Onglyza, respectively. With the recent nod from the European Commission, AstraZeneca can now work on Qtern’s market share ahead of the launch of its drug counterpart from Eli Lilly and Co (NYSE:LLY) and Boehringer Ingelheim’s, Glyxambi.
The main function of Qtern is to improve glycemic control. The European Commission based its approval on three clinical trials evaluating the safety and efficacy of the formulation in aiding type 2 diabetes patients.
Elisabeth Bjork, AstraZeneca Vice President (VP) and Head of Cardiovascular and Metabolic Diseases for Global Medicines Development, boasted that Qtern is indeed the first of its kind to receive the approval of the European Commission. Consequently, the recent event signifies an important accomplishment in furthering new treatment options for those who are suffering from type 2 diabetes. Presently, almost half of type 2 diabetes patients are at risk of complications arising from hyperglycemia.
With the US FDA accepting generic versions of Crestor for marketing, the company is expected to lose a significant market share. Crestor costs about $260 per month and with the entry of generics in pharmacies, patients are looking at a savings rate of about 80% to 90%.
As support for generic drugs continues to grow, big branded drugmakers like AstraZeneca are in the midst of losing massive profitability.
The US FDA also rejected AstraZeneca’s application for Qtern in late 2015. As a result, analysts had projected that the rejection will significantly slow AstraZeneca’s progress. Nonetheless, with the go signal of the European Commission, it appears that the company remains somewhat on track.