Drug firm AstraZeneca Pharma India on Saturday said it has received approval from Drugs Controller General of India (DCGI) for Dapagliflozin tablets for treatment of patients suffering from heart failure with reduced ejection fraction.
The company has received import and market permission from DCGI in Form CT-20 (Marketing Authorisation- Additional Indication). The receipt of the permission paves the way for launch of Dapagliflozin film coated tablet 10mg in India, AstraZeneca Pharma India said.
The drug is already being sold in the country as a diabetic medicine used for lowering blood sugar in adults with 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 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 life threatening disease in which the heart muscle is unable to pump enough blood to meet the body's needs for blood and oxygen.
"Heart Failure is a serious health condition that affects around 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 and live longer," AstraZeneca Pharma India MD Gagandeep Singh said.
On being asked about the market size the company is eyeing with this approval, Singh told PTI: "As we heard, there are 8 to 10 million patients in India who suffer from heart failure, so there is an immense amount of patient burden out there which needs to be addressed".
It's potentially the number one cause of hospitalisation as well. So, there is a huge economic burden which is attached to this disease apart from the mortality, he added in a virtual press conference.
"Therefore we are very excited that we are participating in this market which is quite significant", Singh said, adding the market is close to Rs 2,000 plus crore.
United States Food and Drug Administration (USFDA) has also approved Dapagliflozin to be used in the management of patients with heart failure with reduced ejection fraction, AstraZeneca said.
Dapaglifozin (Forxiga) is also indicated as an adjunct to diet and exercise to improve glycaemic control in adults with Type 2 diabetes in India.