Kiersten Combs Discusses Scientific Research and Possible Future Indications for Dapagliflozin

We are in the regulatory process to get an indication for the treatment of heart failure in both type 2 and non-type 2 diabetic patients, and this serves as just the start of the scientific investment that we have made with dapagliflozin, said Kiersten Combs, BS, U.S. vice president of Cardiovascular Metabolism at AstraZeneca.

Transcript

The FDA expanded the label for dapagliflozin in October to reduce heart failure in groups of patients with type 2 diabetes and cardiovascular disease. What will be the next indication that AstraZeneca will seek for dapagliflozin?

Based off the DAPA-HF data, we are in the regulatory process to get an indication for the treatment of heart failure in both type 2 and non-type 2 diabetic patients; but beyond that, that's just the beginning. We also are studying FARXIGA [dapagliflozin] in CKD patients, as well as, later on we have a study going on in HFpEF [heart failure with preserved ejection fraction] in heart failure also. So, really what you've seen with the label update that we had last month, what you're seeing with the data that's being presented with DAPA-HF, is just the start of the scientific investment that we've made with FARXIGA.

The early data also showed that the heart failure benefit increased for patients who are obese. Is this a group that should receive consideration in a future label expansion?

We're in the process, and some of the data that we're presenting here at AHA 2019 is looking at different patient characteristics, whether it be obesity or age, and also looking at the time in which you could see impact—a positive clinical impact in patients with heart failure. All of these data will be part of what we take forward and discuss with the FDA around future labels.