New & advanced treatment option for heart failure now available in India;
PUNE, 6 July 2020: AstraZeneca India (AstraZeneca Pharma India Limited), a leading science-led biopharmaceutical company, today received the government approval for Dapagliflozin (Forxiga), for the treatment of patients with heart failure. This is the first antidiabetic drug approved for the treatment of heart failure (HF) and is the first drug proven to reduce the risk of Cardiovascular death and hospitalisation.
The approval is based on the results from the DAPA-HF study, which proved that Forxiga in addition to standard of care, reduced the risk of Cardiovascular death or the worsening of Heart Failure by 26%. About one-fourth patients in the study population were from the 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 oxygen. 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 the 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). It is the leading cause of hospitalization for those over the age of 65 and represents a significant clinical and economic burden. Further, the mean age of Heart Failure is 61.2 years in Indians, at least a decade earlier than the western population.
Gagandeep Singh, Managing Director, AstraZeneca Pharma India Limited 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”
Dr. Jagadish S Hiremath, Senior Interventional Cardiologist, Director Cath Lab, Ruby Hall Clinic said, “Multiple studies have shown that Heart failure is becoming a major burden to people above 45yrs and tends to progressively increase with age. In the clinical setting, effective management of heart failure has been a long-time requirement. With the approval of Dapagliflozin for heart failure, physicians will now have an additional option to manage patients more effectively”
Dapagliflozin (Forxiga) is also indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes in India. The drug is also approved for the reduction of risk of hospitalization due to Heart failure in type 2 diabetes patients with high-risk factors.
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