AstraZeneca Pharma India received the marketing authorization for dapagliflozin (Forxiga) from the Drugs Controller General of India (DCGI) 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. It is also the first drug proven to significantly reduce the risk of cardiovascular death and hospitalization for heart failure in patients with HFrEF. Forxiga is used for the treatment of diabetes too.
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 HFrEF versus placebo by 26%.1About one-fourth patients in the study population were from Asian region including India.
The drug under underwent global studies across 20 countries roping in 4,744 patients. From India there the human studies were conducted at 18 sites and led by the national investigator Dr VK Chopra senior, director, Max Super Specialty Hospital and founder president, Heart Failure Association of India in 2013 said Dr. Anil Kukreja, vice president – medical affairs & regulatory, AstraZeneca India at a webinar to announce the approval from the DCGI.
The approval for dapaglifozin 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 heart failure. 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 Dr Kukreja.
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 where at least half of which have reduced ejection fraction, including at least 8 to 10 million patients in India.
Gagandeep Singh, managing director, AstraZeneca Pharma India said that the accelerated regulatory approval in India will provide the much-needed treatment to help patients reduce their disease burden & live longer.
“We already have a strong cardiovascular and metabolic disease drug portfolio. In the cardiovascular segment Brilinta (ticagrelor) is a classic example. Although there is a commonality of the diseases: diabetes and HF being chronic conditions, the differentiating factor with Forxiga is that it can be prescribed to those without diabetes too. The drug is priced at Rs 57 per tablet and prescribed as a once a day protocol, added Singh.
The US 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 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 reduction of risk of hospitalisation due to heart failure in type 2 diabetes patients with high risk factors.