Last week the FDA granted its fast track designation to the SGLT-2 inhibitor, empagliflozin, in heart failure. This designation is provided to drugs which are believed to fill an unmet medical need in order to facilitate their development and expedite their review.
This fast track status applies to two ongoing Phase III studies, (EMPERIAL-preserved and EMPERIAL-reduced), which are investigating the impact of empagliflozin on exercise ability and heart failure symptoms in people with chronic heart failure independent of whether they have type 2 diabetes.
Empagliflozin is currently approved for the treatment of type 2 diabetes, and as an adjunct to diet, exercise and standard of care to reduce the incidence of CV death in patients with type 2 diabetes and established CVD. The latter approval was based on favourable results from the CV outcomes trial, EMPA-REG OUTCOME. This trial also showed significant reductions in the risk of hospitalization for heart failure in patients with type 2 diabetes and established CVD, and formed the rationale for further exploration in patients with heart failure.
Studies with other SGLT-2 inhibitors (i.e dapagliflozin) are also underway in patients with heart failure and suggest this class could provide a promising new management strategy for these patients. Heart failure is believed to affect over 26 million people worldwide and is one of the most common causes of hospitalization. We look forward to the results of these trials and the impact this treatment could have for patients with heart failure!