AZ says Brilinta hits the mark in diabetic heart disease

AstraZeneca has chalked up another clinical trial win for its antiplatelet drug Brilinta, showing that it can reduce cardiovascular events in diabetics with coronary artery disease (CAD).

The results of the 19,000-patient THEMIS trial will now form the basis of a regulatory filing later this year to expand the label for Brilinta (ticagrelor) for this high-risk patient population, according to the company.

The study showed that in diabetics with CAD and no prior history of heart attack or stroke, Brilinta given on top of aspirin therapy achieved a statistically-significant reduction in a composite of major adverse cardiovascular events (MACE) compared to aspirin alone.

Brilinta was held up as one of the growth pillars of AZ’s product portfolio when the company was fending off a takeover from Pfizer a few years ago. While it hasn’t matched the growth rate needed to meet AZ’s optimistic forecast of $3.5bn by 2023, it has still been a valuable earner for AZ with sales of $1.3bn last year, rising around 21% year-on-year.

In the meantime AZ’s new oncology drugs have taken the pressure off Brilinta, but the new data could lend additional momentum to the product and take it further into blockbuster territory. Meanwhile, next year, AZ is also expecting a phase 3 readout in the THALES trial of Brilinta as a treatment for in acute ischemic stroke and transient ischaemic attack, that could lead to a filing.

“Patients who have both stable coronary artery disease and diabetes are a sizeable group which remains at particularly high risk of major adverse cardiac events,” commented THEMIS co-chair Gabriel Steg of Imperial College, London.

“The optimal long-term antiplatelet therapy in that group is not fully established. We look forward to presenting the full results from the THEMIS trial later this year.”

It’s not all been positive for Brilinta in the last couple of years, with the drug failing to show efficacy in back-to-back stroke and peripheral artery disease (PAD) trials in 2016, at which point AZ confessed its $3.5bn target was probably unachievable.

Last year, the GLOBAL LEADERS study last year also showed that discontinuing aspirin after a month and starting monotherapy with ticagrelor was no better than aspirin plus Brilinta or clopidogrel in patients undergoing interventions for acute coronary syndrome (ACS) or stable CAD.

Brilinta is already approved to reduce risk of heart attacks and strokes in adults with ACS, and preventing further atherothrombotic events after an initial heart attack.