AZ’s therapy to reduce cardiovascular death and hospitalisation

Pharma News: The indication for AstraZeneca’s heart failure treatment has been extended to include the treatment of symptomatic heart failure with reduced ejection fraction (HFrEF) in adults, as an adjunct to standard of care therapy.

Forxiga (dapagliflozin) is the first SGLT2 inhibitor to be TGA approved in Australia for heart failure patients with reduced ejection fraction.

Heart failure (HF) is a life-threatening chronic disease affecting more than 100,000 Australians, over half of whom have a reduced ejection fraction.

The extended indication for Forxiga in Australia follows the publication of the Phase III DAPA-HF clinical trial in The New England Journal of Medicine. The data demonstrated a 26% reduction in the risk of the composite outcome of cardiovascular death or the worsening of heart failure above standard care versus placebo. 

According to Professor Andrew Coats, cardiologist and Professor of Cardiology at Monash and Warwick Universities, the new approval in Australia could be an important step in developing a new model of care for heart failure in the future.

“I certainly welcome the approval of new evidence-based treatment options for Australians affected by heart failure, especially in the primary care setting. New treatment options that reduce cardiovascular death and hospitalisation, while also improving symptoms, are urgently needed,” said Professor Coats.

This TGA registration will now allow clinicians to use Forxiga as an adjunct to the standard of care in the treatment of heart failure with reduced ejection fraction (HFrEF).

Dr Anita Sharma, Brisbane-based general practitioner and member of the RACGP Education Committee, said the treatment of heart failure was a complex area for GPs, given the need for careful titration with existing medications.

“Primary care doctors are already familiar with SGLT2 inhibitors because of their role in treating type 2 diabetes. GPs are often the first point of contact for the majority of heart failure patients. They are ideally placed in diagnosing, initiating and optimising medications and monitoring heart failure in their patients. We need to ensure GPs are well educated and briefed about the appropriate place of this new option in heart failure patients,” said Dr Sharma.

Liz Chatwin, Country President at AstraZeneca Australia and New Zealand, said the new indication for Forxiga reflects a positive move towards improving the access to evidence-based treatments for heart failure.

“We are delighted to have the opportunity to provide Australians with heart failure, and the healthcare professionals who treat them, with an accessible option to better manage this condition. It is through continued research that we are able to see these promising changes in clinical treatment,” said Ms Chatwin.