AstraZeneca makes case for use of blood thinner Brilinta in stroke patients
AstraZeneca’s extravagant projections for its clot fighter Brilinta may have fizzled in the face of underwhelming trial data — but a new pivotal study is set to expand its use substantially.
On Monday, the British drugmaker said the drug, when taken in conjunction with aspirin, induced a statistically significant reduction in the risk of the primary composite endpoint of stroke and death, compared to aspirin alone, in 11,000 patients that have suffered minor acute ischemic stroke or a high-risk transient ischemic attack (TIA).
Detailed data from the trial, dubbed THALES, are still to come.
There are about 2.2 million ischemic stroke patients in major markets, which is a substantial expansion over the current acute coronary syndrome (ACS) indication of roughly 4.3 million patients, Jefferies analyst Peter Welford wrote in a note, forecasting $2.5 billion in global peak sales, assuming patent expiry by 2024.
The drug generated roughly $1.15 billion in the first nine months of last year and was AstraZeneca’s third-biggest seller.
In 2016, AstraZeneca started edging away from its $3.5 billion peak revenue projection for the drug after it failed two big studies, dealing a blow to Brilinta’s prospects. In particular, in the SOCRATES trial, Brilinta failed to differentiate itself from aspirin in patients with acute ischemic stroke or transient ischemic attack.
In a separate trial, the drug proved no better than aspirin alone in reducing the risk of death, stroke or heart attack in patients with peripheral artery disease. However, in 2017 — as part of a sub-group analysis — the clot fighter was shown to induce a substantial 29% reduction in the risk of cardiovascular death in patients who had previously suffered a heart attack and who continued to take the treatment as well as aspirin past the first full year of therapy.
In 2019, THEMIS headline trial results suggested that the drug — in conjunction with aspirin — showed a statistically significant reduction on a composite endpoint of major adverse cardiovascular events (CV death, myocardial infarction or stroke) in diabetics with coronary artery disease with no prior heart attack, myocardial infarction, or stroke, compared to aspirin alone.
However, detailed data on the blood thinner from the 19,000-patient trial later showed that the benefit was accompanied by a significantly higher risk of major bleeding. In addition, the incidence of intracranial hemorrhage and fatal bleeding were also higher in the Brilinta group.