Reversing a negative decision taken back in 2012, the U.S. Food and Drug Administration approved on Wednesday AstraZeneca’s dapagilflozin, which will be sold as Farxiga in the U.S., to help improve the glycemic control, along with exercise and diet, in adults that have type 2 diabetes.
Dapagilflozin is a SGLT2 inhibitor that AstraZeneca will have full rights to under its recent deal in diabetes with Bristol-Myers Squibb. The drug already has approval in the European Union’s 28 nations, where its brand name is Forxiga. It is also approved in Mexico, Iceland, Brazil, Australia and Argentina.
Only last month, an advisory committee for the FDA voted 13-1 that dapagliflozin’s benefits outweigh the known risks and support the marketing of the drug as being an adjunct to exercise and diet to improved the glycemic control for adults suffering from type 2 diabetes.
The committee at the same time voted 10-4 that the information provided enough evidence that the drug, relative other comparable, has a cardiovascular risk profile that is acceptable.
The effectiveness and safety of Farxiga were evaluated via 16 different clinical trials that involved over 9,400 patients that suffered from type 2 diabetes. Those trials showed an improvement in the measure of control of blood sugar. However, bladder cancer diagnosis amongst users of Farxiga increased in the clinical trials. Therefore, the drug has not been recommended for diabetes patients that have active bladder cancer, noted the FDA report.
Through its approval, the FDA will require six studies post-marketing for Farxiga.
- A cardiovascular outcomes (CVOT) trial that will evaluate the risk in patients who use Farxiga that have a high baseline risk for a cardiovascular disease.
- A randomized double blind controlled assessment of the risk of bladder cancer for patients in the CVOT.
- A study with animals that evaluates the role of composition and urinary flow rate changes on bladder tumor promotion for rodents.
- Two other clinical trials that assess the efficacy, safety and pharmacokinetics in pediatric patients.
- A program for pharmacovigilance that is enhanced to monitor the reports of pregnancy outcomes and liver abnormalities.