The biopharmaceutical firm AstraZeneca Pharma India Limited announced that the company has received marketing approval from the Drug Controller General of India (DCGI) for dapagliflozin (Forxiga) for the treatment of adult patients with heart failure with reduced ejection fraction (HFrEF).
The sodium-glucose cotransporter-2 (SGLT2)-inhibitor drug is a once-daily oral drug which is already being sold in the country as an anti-diabetic medication for type 2 diabetes.
“This is the first in class SGLT-2 inhibitor drug approved for the treatment of heart failure with reduced ejection fraction (HFrEF) and is the first drug which is studied and proven to significantly reduce the risk of cardiovascular death and hospitalisation for heart failure in patients with HFrEF,” the company said in a statement.
Heart failure is a condition where the heart is unable to pump blood at a rate commensurate with the requirements of the tissues or can do so only at high pressures.HFrEF is a type of HF where there is an impaired ejection of blood due to the damage of walls of the left ventricle resulting in its reduced ability to pump or eject the blood. EF is the percentage of blood that is pumped out of the heart during each beat which normally is measured as 50% whereas in HFrEF would be ≤ 40%. This type of HF is a relatively prevalent form of HF in India, said Dr Vijay Kumar Chopra, Senior Director -Max Super speciality Hospital and Chief of Cardiological Society of India Heart Failure Council 2020-2022.
The current estimates about the incidence of HF may vary around 8-10 million patients in India with HFrEF being predominantly observed in 53% of the population suffering from heart failure with most patients getting affected at a younger age.
The approval was based on the results from the international, multicentric, randomised DAPA-HF (Dapagliflozin and Prevention of Adverse- outcomes in Heart Failure) trial which was conducted in patients with HFrEF (EF ≤ 40%) with and without type 2 diabetes. The trial evaluated the effect of dapagliflozin (10mg), compared with placebo, given once daily in addition to standard of care.
DAPA-HF trial was conducted in 20 countries including about 4,744 participants, of which 237 participants were from India. Adult patients above 18 years from old across India having HF with HFrEF were involved as per the eligibility criteria, said Dr.Anil Kukreja, Vice President – Medical Affairs & Regulatory, AstraZeneca Pharma India Limited
In the trial dapagliflozin was found to significantly reduce the cardiovascular death and worsening of HF by 26% compared to the placebo on top of the standard of care, he added.
The cardiovascular deaths were reduced by 18% compared to the placebo. The risk of worsening of HF was reduced by 30%. The benefits were found in both the diabetic and non-diabetic groups. The findings showed that there was a 27% HF risk reduction in non-diabetic cases while 25% of risk reduction was found in diabetic patients.
“In this trial, nearly 60% of patients were non-diabetic while 40% were diabetic. The drug was equally effective in both. The incidence of adverse events was almost equal to that of placebo; that is there were hardly any significant adverse events. Thus even in the non-diabetic patient, there was no significant incidence of low blood sugar,” said Dr Chopra who was also the National Coordinating Investigator for the DAPA -HF trial in India.
The drug has received the US FDA approval in May for use in patients with mild to moderate HF due to HFrEF (LVEF≤40%) and concomitant type 2 diabetes, to improve symptoms and quality of life and to reduce the risk of hospitalisation and cardiovascular mortality.