AstraZeneca's diabetes drug Farxiga met a key goal in a major clinical study designed to show its heart-protecting benefits in a wide range of patients, potentially distinguishing it from rivals in a crowded marketplace.
Diabetics are at increased risk of heart problems, making the cardiovascular (CV) profile of medicines to treat the condition an important focus for doctors and patients.
In the 17,000-patient trial known as Declare, patients on Farxiga achieved a statistically significant and clinically important reduction in hospitalization for heart failure or CV death compared with those on placebo, the company said on Monday.
There were also fewer major adverse cardiovascular events, although in this case the difference did not reach statistical significance.
The failure to achieve a more convincing reduction in CV events - such as heart attacks and strokes - may be seen as disappointing. But Ludovic Helfgott, AstraZeneca’s head of CV and metabolic diseases, believes the overall data suggests Farxiga could win expanded approval as a diabetes drug with proven heart benefits in a wide range of patients.
Full results from the Declare study will be presented on Nov. 10 at the annual meeting of the American Heart Association.
"We have demonstrated with Declare that we have a cardiovascular outcome in a broad population and we believe that is something that needs to be recognized by regulators and the clinical community," Helfgott told Reuters.
"We are expecting to have a new label by the end of next year."
Farxiga competes with rival diabetes drugs including Eli Lilly and Boehringer Ingelheim's Jardiance and Novo Nordisk's Victoza, which have already shown improved outcomes in patients with established heart problems – known as secondary prevention.
AstraZeneca's big study goes a step further by aiming to demonstrate Farxiga's value in patients without established CV disease, opening up a larger market that also covers so-called primary prevention.
"This should provide a degree of commercial differentiation," UBS analyst Jack Scannell said in a note.
The primary prevention population is around three times larger than that for secondary prevention, industry analysts estimate.
Deutsche Bank analyst Richard Parkes said the latest data should help secure the future of AstraZeneca's diabetes business, which has tended to get less attention than its high-profile oncology unit.
Consensus analyst forecasts currently point to Farxiga achieving annual sales of $2.7 billion by 2023, up from an expected $1.4 billion this year, according to Thomson Reuters data.
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