FDA fast-tracks Lilly/Boehringer’s Jardiance for heart failure

Eli Lilly and Boehringer Ingelheim’s Jardiance was the first diabetes drug to lower the risk of cardiovascular disease in a clinical trial, and is now on course to be the first to have a chronic heart failure (CHF) claim on the label.

The FDA has just agreed to fast-track its review of the SGLT2 inhibitor for the reduction of the risk of cardiovascular death and hospitalisation for heart failure in people with CHF, based on the ongoing EMPEROR trials programme which started in 2017.

As their names suggest, EMPEROR-Reduced and EMPEROR-Preserved split the CHF population into those with reduced or preserved ejection fraction, and are due to generate results in 2020. They are massive trials, collectively enrolling almost 9,000 patients including subjects both with and without diabetes.

Boehringer and Lilly are also running another pair of trials, called EMPERIAL, which are investigating the possible benefits of Jardiance on exercise capacity and heart failure symptoms and are due to read out before the end of this year.

It’s an indication of the pressing need for new therapies for CHF that the FDA has already awarded the fast-track status for Jardiance (empagliflozin), well ahead of the trials readout. There are around 6.5 million people with CHF in the US alone and 26 million worldwide, and around half of all those who develop the condition are dead within five years.

“Heart failure contributes to one in nine deaths and is a leading cause of hospitalisation in the US, yet there are limited treatment options for people living with this debilitating disease,” said Mohamed Eid, Boehringer’s head of clinical development.

“We look forward to working closely with the FDA as we explore the potential for [Jardiance] to improve outcomes for adults with CHF.”

Jardiance has become the top-selling drug in the SGLT2 inhibitor class with sales of around $2 billion last year, helped by side-effect problems that have afflicted Johnson & Johnson’s first-to-market Invokana (canagliflozin).

The shift into cardiovascular risk reduction has been another big factor in its success, spurred by the EMPA-REG trial in 2015 which showed that the drug reduced major cardiovascular events (MACE) in diabetic patients by 14% compared to placebo.

J&J and other SGLT2 inhibitor developers like AstraZeneca with Farxiga (dapagliflozin) have tried to follow Jardiance down the cardiovascular outcomes path, and both companies now have data showing they can reduce MACE in diabetic patients. J&J got approval for a cardiovascular outcomes claim for Invokana from the FDA last October.

Analysts at Evercore ISI have suggested that Jardiance could hit sales of $4 billion at its peak, and the cardiovascular outcomes data that could extend its use beyond diabetes is expected to be a big factor in that growth.