Astrazeneca’s Dapagliflozin gets DCGI nod for treatment of heart failure

AstraZeneca Pharma India has received the Marketing Authorization for Dapagliflozin (Forxiga),  for the treatment of patients with heart failure with reduced ejection fraction (HFrEF). This is the first in class SGLT-2 inhibitor drug approved for the treatment of HFrEF. Reportedly, it is the first drug proven to significantly reduce the risk of cardiovascular death and hospitalisation for heart failure in patients with HFrEF.

The approval follows positive results from the landmark Phase III DAPA-HF trial,  that proved that Dapagliflozin in addition to standard of care, reduced the risk of the composite outcome of cardiovascular death or the worsening of heart failure versus placebo by 26 per cent.  About one-fourth patients in the study population were from the Asian region including India.

Gagandeep Singh, MD, AstraZeneca Pharma India said, “ Heart failure is a serious health condition that affects ~6.4 crore people worldwide and at least 8–10 million in India. The accelerated regulatory approval in India will provide the much-needed treatment to help patients reduce their disease burden and live longer”

Dr Anil Kukreja, VP – Medical Affairs & Regulatory, AstraZeneca India said, “This approval for Dapaglifozin (Forxiga) based on significant and clinically meaningful results from Dapa-HF trial provides much-required confidence on a novel pharmacological approach, first in class SGLT2 inhibitor, for management of patients with HFrEF. This approval is a boon for HFrEF patients in India where considerable efforts are required to address significant unmet needs of frequent hospitalisation, urgent visits to hospital emergency room and cardiovascular death in HF patients despite available therapies ”

The US Food and Drug Administration (US FDA) approved Dapagliflozin to be used in the management of patients with heart failure with reduced ejection fraction. The Canadian Cardiovascular Society has updated their guidelines and recommend the use of SGLT2i drugs like Dapagliflozin to manage heart failure to provide better patient care.

Dapaglifozin (Forxiga) is also indicated as an adjunct to diet and exercise to improve glycaemic control in adults with T2D in India. The drug is also approved for the reduction of risk of hospitalisation due to heart failure in Type 2 diabetes patients with high-risk factors.