AZ backs diabetes drug Farxiga with new cardio analysis

AstraZeneca continues to make the case for its Farxiga diabetes drug, highlighting a cardiology analysis that it hopes will convince more doctors to prescribe it in a highly competitive market.

Farxiga (dapagliflozin) is AZ’s fifth biggest selling drug, making up around 7% of product sales.

Last year’s sales of nearly $1.4 billion were a 30% year-on-year increase, but its main US patent is set to expire next year, and its EU patent in 2023.

So AZ is trying to make the most of the drug it acquired from Bristol-Myers Squibb after buying out the latter’s share in a diabetes partnership struck at the beginning of the decade.

There are a range of other diabetes drugs that have the dual effect of reducing blood sugar, while at the same time reducing the risk of cardiovascular (CV) events in high-risk patients.

These include Eli Lilly/Boehringer Ingelheim’s Jardiance (empagliflozin), a rival from the SGLT-2 inhibitor class and the first diabetes drug to show a cardioprotective effect in high-risk patients.

A new analysis of the phase 3 DECLARE-TIMI 58 trial showed Farxiga reduced the relative risk of major adverse cardiovascular events (MACE) by 16% compared with placebo in patients with type 2 diabetes who had a prior heart attack.

In another pre-specified sub-analysis, Farxiga compared to placebo reduced the relative risk of hospitalisation for heart failure in patients with T2D regardless of their ejection fraction status, a measurement of the percentage of blood leaving the heart with each contraction.

These pre-specified sub-analyses of DECLARE-TIMI 58 build on positive primary results of the trial presented in November 2018, which showed that Farxiga significantly reduced the risk of the composite of hospitalisation for heart failure or CV death compared to placebo, consistently across the trial’s entire patient population.

There were fewer major adverse cardiovascular events observed with Farxiga in the broad patient population, however this did not reach statistical significance.

The AZ-sponsored randomised controlled trial involved 17,000 patients across 882 sites in 33 countries and was independently run in collaboration with academic investigators from the TIMI study group in Boston, US, and the Hadassah Hebrew University Medical Center in Jerusalem, Israel.

Dr Stephen Wiviott of Brigham and Women’s Hospital and Harvard Medical School, a senior investigator with the Thrombolysis in Myocardial Infarction (TIMI) study group and co-principal investigator of the trial, said: “Data from these pre-specified sub-analyses offer important and clinically-relevant insights for cardiologists and their patients.

“We now have new evidence from DECLARE-TIMI 58 that shows Farxiga consistently reduced hospitalisation for heart failure across a broad range of patients with type-2 diabetes, regardless of their history of existing CV disease, including heart attack, or heart failure.”