AstraZeneca announced in a recent press release that Farxiga (dapagliflozin) has been approved in the US for the risk of cardiovascular death, hospitalisation for heart failure (HF), and urgent HF visits in adults with HF. Farxiga is an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor previously approved for HF with reduced ejection fraction in adults. GlobalData believes that Farxiga’s approvals will help a broader range of patients with HF in the US. AstraZeneca is expected to see a significant boost in its revenues.  

Farxiga’s recent FDA approvals were supported by the DELIVER Phase III trial. The trial demonstrated that Farxiga reduced the risk of hospitalisation and mortality from a cardiovascular event by 18% in patients with mildly reduced or preserved ejection fraction. In addition, the safety and tolerability profiles were consistent with the well-established safety profile of the medicine.

Farxiga is expected to have such a strong influence on the market due to the impressive results and valuable evidence seen in trials. Farxiga fills an unmet need in the HF space by substantially reducing mortality and hospital readmission rates while maintaining tolerability and safety. The drug has paved the way for the establishment of an SGLT2 inhibitor class effect in HF, and this is expected to drive further research and development in this area. Currently, the majority of marketed drugs simply slow the progression of the disease, reduce mortality, and reduce HF hospitalisations. The ideal HF therapy must demonstrate regenerative potential, repair cardiac damage, and reverse disease progression. However, regenerative therapies come with high price tags, and since highly priced drugs have struggled to penetrate the HF market, this may deter drug developers from pursuing such a therapy.

Farxiga is expected to see an increase in uptake with the approval of additional indications, granting AstraZeneca a majority share of the total HF market.