AZ unveils phase 3 Brilinta data in CAD and type 2 diabetes

AstraZeneca unveiled the full data set from its phase 3 THEMIS trial at the ESC 2019, which investigated Brilinta in patients with coronary artery disease (CAD) and type 2 diabetes. 

The study demonstrated that Brilinta plus aspirin reduced the risk of cardiovascular death, heart attack or stroke by 10% compared to aspirin alone. The observed patient population included patients with CAD and type 2 diabetes who had not previously had a heart attack or stroke.

In addition, the drug also demonstrated a 15% relative risk reduction in patients who had previously undergone a percutaneous coronary intervention (PCI), a procedure to open a blocked or narrowed coronary artery.

However, the potential of Brilinta as a preventive treatment for cardiovascular events could be limited by the treatment causing an increased risk of major bleeding. Brilinta carried an increased risk of major bleeding (2.2%) compared to the control group (1%). Additionally, the risk of intracranial haemorrhage also increased with Brintila when compared to the control group (0.7% v 0.5%).

Brilinta is already approved to reduce the risk of heart attacks and strokes in adults with acute coronary syndrome and preventing further atherothrombotic events after an initial heart attack. For AZ, the treatment is a potential growth pillar, with the company predicting a growth rate of $3.5bn by 2023. However, it is unlikely that Brilinta will be able to match this optimistic forecast, but it has still been a valuable earner for AZ with sales of $1.3bn last year and rising around 21% year-on-year.

In addition to Brilinta, AZ presented the full results from its DAPA-HF trial of its diabetes therapy Farxiga in heart failure with reduced ejection fraction (HFrEF). The Farxiga results were met with a more enthusiastic response, with DAPA-HF being described as a ‘landmark trial’.

AZ had hopes to expand the label for Brilinta into this high-risk patient population, with the THEMIS trial intended to form the basis of a regulatory filing later this year. However, the full set of results could undercut this expansion, with healthcare regulators potentially wary of the increased risk of bleeding events.