Farxiga faces first heart failure rival as EU OKs Boehringer/Lilly's Jardiance

AstraZeneca's SGLT2 inhibitor Farxiga has been growing fast thanks to a first-in-class approval in heart failure, but will now have to share the market with Boehringer Ingelheim and Eli Lilly's rival therapy Jardiance. 

The European Commission has become the first regulator to approved Jardiance (empagliflozin) as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), also known as systolic heart failure.

Jardiance, Farxiga (dapagliflozin) and other SGLT2 drugs are already widely used to treat type 2 diabetes, and their developers have long had aspirations to expand their use into other cardiometabolic disorders, including heart failure and chronic kidney disease (CKD).

AZ stole a march on its rivals after it claimed approval for Farxiga as a treatment for HFrEF in the US in May 2020 and in Europe the following November. That helped drive sales of the drug up 30% to almost $2 billion last year, and more than 50% to $624 million in the first three months of this year.

That was followed by another first-in-class FDA approval for Farxiga in CKD in April, leaving Boehringer/Lilly playing catch-up with Jardiance once again.

Now, the approval of Jardiance for HFrEF in Europe – with an FDA decision due in the coming weeks – gives them a chance to reset the playing field. A readout in CKD from the EMPA-Kidney is expected next year.

The approval is based on the results of the EMPEROR-Reduced trial, which showed that Jardiance cut the risk of cardiovascular death or hospitalisation for HFrEF by 25% compared to placebo in patients, regardless of whether they had diabetes.

Lilly and Boehringer claim almost 60% market share for Jardiance among SGLT2 drugs, reporting sales of nearly $1 billion and $3 billion respectively, helped by data showing it could reduce cardiovascular complications in diabetic patients.

Both Jardiance and Farxiga have also benefited from side-effect problems – specifically amputation risks – that have afflicted first-to-market rival Invokana (canagliflozin) from Johnson & Johnson. The FDA removed the boxed warning for those risks last year but the product hasn’t recovered commercially.

As the marketing tussle between AZ and Boehringer/Lilly moves into the heart failure category, all eyes are now on upcoming data readouts in heart failure with preserved ejection fraction (HFpEF), a much more challenging indication.

Boehringer/Lilly are running the EMPEROR-Preserved trial while AZ has the DELIVER study on the go in HFpEF, which are due to generate results this year and in early 2022, respectively.

GlobalData has said that the lead in heart failure could push sales of Farxiga head of Jardiance in 2028, at $9 billion and $4.6 billion respectively, assuming they also get approved for the HFpEF indication.