FDA approves AZ’s Farxiga in new heart failure prevention use

The FDA has approved AstraZeneca’s diabetes drug Farxiga to reduce the chances of hospitalisations for heart failure in adults with type 2 diabetes and other cardiovascular risks.

This is the first of several indication expansions that could build further sales for the blockbuster drug, ahead of a likely US patent expiry in around a year’s time.

Approval in this new use in the US follows results from the DECLARE-TIMI 58 clinical trial, which have already led to an expanded label in the EU, where the drug is patent protected until 2023.

Farxiga’s new indication is also under regulatory review in China with a decision anticipated in the first half of 2020.

DECLARE-TIMI 58 showed that Farxiga (dapagliflozin) was able to reduce hospitalisations for heart failure and cardiovascular death in a broad diabetes patient population, most of whom had no cardiovascular disease at enrolment, compared with placebo.

There were fewer major cardiovascular events (MACE) observed, although while there were fewer strokes with Farxiga, another efficacy goal, the improvement was not significant.

AZ noted that this is the first drug in the SGLT2 class to be approved in this indication in the US, potentially allowing it to gain sales in a competitive environment against rivals including Eli Lilly/Boehringer Ingelheim’s Jardiance (empagliflozin).

Farxiga is one of AZ’s most important drugs, and sales increased by 14% to $726 million in the first half of the year, although this was slower than the growth seen in 2018 when sales grew at 30% to $1.39 billion.

There could be more to come from Farxiga too: the FDA has granted Fast Track designation for Farxiga to reduce the risk of CV death, or the worsening of heart failure in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF) based on the Phase 3 DAPA-HF and DELIVER trials.

The FDA has also granted Fast Track designation to delay the progression of renal failure and prevent CV and renal death in patients with chronic kidney disease (CKD) based on the Phase III DAPA-CKD trial.

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