Study puts Jardiance in hot pursuit of AZ’s Farxiga in heart failure

The FDA’s approval of AstraZeneca’s SGLT2 inhibitor Farxiga in heart failure was a first for the class, but Boehringer Ingelheim and Eli Lilly are closing the gap with a positive pivotal trial for their rival drug Jardiance.

Top-line data from the phase 3 EMPEROR-Reduced study have shown that Jardiance (empagliflozin) beat out placebo on the primary objective of reducing death and hospitalisation rates in heart failure patients with and without diabetes.

The study was carried out in heart failure patients with reduced ejection fraction (HFrEF), the same group for which AZ claimed an FDA approval for Farxiga (dapagliflozin) in May.

Boehringer and Lilly now plan to present the data from EMPEROR-Reduced at the European Society of Cardiology (ESC) congress next month, and start filing for approval of Jardiance for HFrEF before the end of the year.

Jardiance was the top-selling drug in the SGLT2 inhibitor class with sales of almost $3 billion last year helped by side-effect problems that have afflicted Johnson & Johnson’s first-to-market Invokana (canagliflozin).

Farxiga has been gaining ground quickly however, with sales topping $1.5 billion in 2019 and growing another 20% in the first half of 2020, despite the impact of the coronavirus pandemic.

“The results of the EMPEROR-Reduced trial indicate that SGLT2 inhibitors have the potential to become a new standard of care for this disease, which will be a meaningful addition to currently established treatments,” said lead investigator Milton Packer of Baylor University Medical Center in Dallas.

Analysts at GlobalData have suggested that heart failure could add billions to the sales of the two SGLT2 inhibitors, particularly if they also claim approvals in heart failure with preserved ejection fraction (HFpEF), a larger patient population.

GlobalData has predicted that Farxiga will reach peak sales of $9 billion in 2028, while Jardiance is forecast to reach $4.6 billion, assuming a launch for HFrEF in 2021.

The bulk of those sales will come from HFpEF, which has “a huge unmet need and no specific standard of care,” it says.

AZ will however start losing patent protection for its drug in the coming years, depending on the outcome of patent litigation, so the launch of generics could rein in the SGLT2 market.

There have been numerous trial failures in HFpEF in recent years, including Novartis’ big selling heart failure therapy Entresto (sacubitril/valsartan), and Farxiga, Jardiance, and Merck & Co/Bayer’s vericiguat are the only drugs with positive data in this form of heart failure.

Boehringer and Lilly are waiting for the results of the EMPEROR-Preserved next year, while AZ is testing Farxiga in the DELIVER trial in HFpEF, with additional data on both HFrEF and HFpEF due from the DETERMINE study. Both of those Farxiga trials are also due to read out in 2021.