Dapagliflozin (Forxiga) is the first SGLT-2 inhibitor proven to significantly reduce the risk of Cardiovascular death and hospitalisation for heart failure in patients with HFrEF.
Chennai, NFAPost: AstraZeneca Pharma India Limited (AstraZeneca India), a leading science-led biopharmaceutical company, today 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 and 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%.1 About one-fourth patients in the study population were from Asian region including India.
Heart failure is a life threatening disease in which the heart muscle is unable to pump enough blood to meet the body’s needs for blood and oxygen2. It affects around ~6.4 crore people worldwide (at least half of which have reduced ejection fraction), including at least 8 to 10 million patients in India.
It is a chronic, degenerative disease where half of patients die within five years of diagnosis. Heart Failure remains as fatal as some of the most common cancers in both men (prostate and bladder cancers) and women (breast cancer) 4. It is the leading cause of hospitalisation for those over the age of 65 and represents a significant clinical and economic burden5.Further, the mean age of Heart Failure is 61.2 years in Indians, atleast a decade earlier than western population.3,4,5
AstraZeneca Pharma India Limited Managing Director Gagandeep Singh 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 & live longer,” said AstraZeneca Pharma India Limited Managing Director Gagandeep Singh.
AstraZeneca India Vice President – Medical Affairs & Regulatory Dr. Anil Kukreja said despite currently available therapies for management of Heart failure, significant unmet needs exist globally as well as in India.
“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 boon for HFrEF patients in India where considerable efforts are required to address significant unmet needs of frequent hospitalization, urgent visits to hospital emergency room and cardiovascular death in HF patients despite available therapies,” said AstraZeneca India Vice President – Medical Affairs & Regulatory Dr. Anil Kukreja.
The U.S. Food and Drug Administration approved Dapagliflozin to be used in 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.
The current estimates about the incidence of HF in India vary widely from 8 to 10 million with HFrEF being predominantly observed in 53% of the population. Indian patients present with HF at a younger age. Prevalence of hypertension and diabetes as comorbidities are very high. Hospital-stay in Indian HF patients is higher due to the higher prevalence of comorbidities.
Prognosis of HF in Indian patients appears to be worse with In-hospital mortality of 9.7%, One-year mortality of 23% and 3 years the mortality of 44.8%. Optimal therapy (OMT) could be initiated in less than 50% of HF patients (BB-48.8%, ACEI/ARB-47.6%) due to multiple comorbidities in Indian patients.
AstraZeneca Pharma India Limited (AstraZeneca India) was established in 1979 and is marking its 40th year of long-standing commitment to patients in India. It is headquartered at Bengaluru, Karnataka. AstraZeneca India has a workforce of over 1,400 employees across the country committed to deliver great medicines to patients through innovative science and global excellence in development and commercialization. For more information, please visit: