Hyderabad: AstraZeneca India (AstraZeneca Pharma India Limited), a leading science-led bio-pharmaceutical company, on Wednesday 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, that proved that Forxigain 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 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 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 hospitalisation for those over the age of 65 and represents a significant clinical and economic burden.Further, the mean age of HeartFailure is 61.2 years in Indians, atleast a decade earlier than 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. Anil Kukreja, Vice President – Medical Affairs & Regulatory, AstraZeneca India 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 clinically meaningful results from the trialprovides much required confidence, for management of patients with Heart Failure. This approval is boon for Heart Failure 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 ”
Dr.Pramod Kumar Kuchulakanti, HOD, cardiology, Yashoda Hospital said, “Incidence of heart failure and its management has been difficult due to limited number of approved medications with minimal adverse effects on the patients. With the approval of Dapagliflozin for Heart failure patients, the options for the management of Heart Failure has widened and is expected to benefit the patients. Now with the drug being available in India, we should be able to provide better quality of treatment to patients in India”
Dapaglifozin (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 reduction of risk of hospitalisation due to Heart failure in type 2 diabetes patients with high risk factors.
About Heart Failure in India: The current estimates about incidence of HF in India vary widely from 8 to 10 millionwithHFrEFbeing predominantly observed in 53% of 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 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.