Farxiga has received the Fast Track designation from FDA for its new indication in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF), AstraZeneca said.
Farxiga is an SGLT2 inhibitor drug which is currently approved and indicated as both monotherapy and as part of combination therapy to improve glycaemic control in patients with Type 2 diabetes (T2D).
The company announced results from the Phase III DAPA-HF trial for Forxiga (dapagliflozin) that showed to reduce incidence of cardiovascular death and the worsening heart failure.
About one-fourth patients in the study population were from Asia including India. The Phase III DAPA-HF trial showed promising results of the SGLT2 inhibitor in patients with heart failure with reduced ejection fraction (HFrEF), with and without type-2 diabetes.
The results of the trial presented at the ESC Congress 2019 in Paris, France, showed Forxiga reduced the composite of cardiovascular (CV) death or worsening of heart failure by 26% (p<0.0001) and showed a reduction in each of the individual components of the composite endpoint.
DAPA-HF enrolled 4,744 patients with heart failure and reduced ejection fraction in 20 countries including India. The results showed a 30% reduction on worsening heart failure events, and mortality reductions of 18% for both cardiovascular and all-cause deaths
Forxiga is well established in the treatment of type-2 diabetes, and these exciting new findings offer clinically meaningful insights into the potential of the medicine to reduce the burden of heart failure in patients with and without type-2 diabetes.”said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D.
AZ reported that Forxiga was as effective in heart failure patients without diabetes as in those with diabetes.
Heart Failure affects approximately 64 million people worldwide, with at least 8–10 million patients in India. Heart Failure is the first complication of type 2 diabetes related cardiovascular disease presenting high mortality risk. According to Global data, nearly 50% of patients diagnosed with Heart Failure succumb within 5 years of diagnosis.
The safety profile of Forxiga in the DAPA-HF trial was consistent with the safety profile of the medicine. The proportion of patients with volume depletion (7.5% versus 6.8%) and renal adverse events (6.5% vs 7.2%), which are commonly of concern when treating heart failure, were comparable to placebo. Major hypoglycaemic events (0.2% versus 0.2%) were rare in both treatment groups.
Dapagliflozin(Forxiga) is currently available and indicated for type 2 diabetes in India and not yet approved for treatment for heart failure in the country.
AstraZeneca has reported that they shall apply for the relevant regulatory approvals globally before it can be specifically used for treating for heart failure.