AZ claims FDA okay for Brilinta in coronary artery disease patients

AstraZeneca’s anti-platelet drug Brilinta has been cleared in the US for a major new indication, preventing a first heart attack or stroke in high-risk patients with coronary artery disease (CAD).

The go-ahead from the FDA is for Brilinta (ticagrelor) in combination with aspirin, and adds to the blockbuster drug’s current uses in the prevention of blood clots in people with acute coronary syndrome (ACS), and to prevent secondary cardiovascular events in high-risk patients who have suffered a heart attack.

It’s a big win for a drug that had been tipped for much greater things a few years ago, but which has been held back by a series of setbacks in clinical trials including studies in stroke and peripheral artery disease (PAD).

That hasn’t stopped it growing into a near $1.6 billion product last year, buoyed by use in emerging markets including China, but is still well short of AZ’s earlier prediction of $3.5 billion in annual sales by 2023.

The approval is based on data from the 19,000-patient THEMIS trial reported last year, which found a 10% reduction in the risk of major adverse cardiovascular events with aspirin plus Brilinta compared to aspirin alone after three years’ treatment.

For a subgroup of patients who had undergone percutaneous coronary intervention, or PCI, there was a 15% relative risk reduction on this endpoint when Brilinta was added to aspirin, although Brilinta treatment was also associated with an increased risk of major bleeding complications.

The trial involved patients with CAD and type 2 diabetes who were at high-risk of a first heart attack or stroke, but the approved indication allows the use of the drug in the non-diabetic setting as well.

“CAD is a potentially life-threatening condition that causes significant morbidity in many people,” said Deepak Bhatt of Brigham and Women’s Hospital and Harvard Medical School, co-chair of the THEMIS trial.

“The addition of ticagrelor to aspirin offers a new therapeutic option to decrease the likelihood of both heart attack and stroke, a significant advance in our ability to treat these high-risk patients,” he added.

Regulatory submissions to expand the approved uses for Brilinta to include the THEMIS data are also under review in the EU, Japan and China, said AZ, which is now looking at peak sales of the drug in the region of $2 billion.

The pressure on Brilinta is a lot less now that AZ’s oncology business is growing at a healthy lick, although analysts say AZ has invested billions of dollars in the trials programme for the drug and needs to get a return before the arrival of generics, expected towards the end of 2024.

There was more good news for AZ on that front earlier this year with the readout of the 11,000-patient THALES trial of Brilinta as a treatment in acute ischemic stroke and transient ischemic attack, showing a reduction in the risk of stroke and death at 30 days.

AZ said at the time it would share the data with regulatory authorities with a view to filing for approval in stroke.