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FDA fast-tracks Jardiance for heart failure review

Would challenge Novartis' Entresto

Lilly

Eli Lilly and Boehringer Ingelheim are looking at a major boost for their co-marketed diabetes treatment Jardiance, as it looks to gain its first ever cardiovascular licence.

Jardiance (empagliflozin) is the leader in the SGLT2 inhibitor class, and in December 2016 became the first ever diabetes drug to gain FDA approval to carry cardiovascular risk reduction claims on its label.

The springboard for this was the FDA’s new requirement for all diabetes drugs to have cardiovascular outcome trials (CVOTs), and this has fuelled an increasing cross-over into heart and stroke trials.

Heart failure remains a major area of unmet need in the therapy area, affecting 26m people worldwide, including more than 6.5 million in the US, with prevalence on the rise.

Around 50% of people diagnosed with heart failure will die within five years, and the condition also represents the most common cause of hospitalisation in the over 65s in the US and Europe.

Lilly and Boehringer are pursuing the drug’s use in heart failure patients in their EMPEROR trial programme.

These studies look at empagliflozin’s impact on cardiovascular death and hospitalisation for heart failure in adults with chronic heart failure with reduced or preserved ejection fraction, respectively.

The FDA has today given the drug fast track review status, with the two separate arms of the trial expected to complete and produce initial results in 2020.

"Boehringer Ingelheim and Lilly are committed to advancing treatments that address the public health challenges of cardiometabolic diseases, including chronic heart failure," said Jeff Emmick, M.D., Ph.D., vice president, product development, Lilly. "We eagerly anticipate results from the EMPEROR studies as we advance the development of empagliflozin in this setting."

A product which has opened up the heart failure market in recent years is Novartis’ Entresto.

It gained approval in 2015 for heart failure patients with reduced ejection fraction, and Novartis is now looking to add a licence in patients with preserved ejection fraction (HFpEF), with read outs expected later this year from its Paragon-HF trial.  After a slow start, sales of Entresto are now growing rapidly, and it broke through the $1bn annual sales barrier last year.

Other contenders looking to meet the needs of heart failure patients include Amgen and Servier, whose omecamtiv mecarbil, recently passed a futility review in its phase 3 study.

26th June 2019

From: Regulatory

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