As Pascal Soriot polishes the rough edges of his R&D shop within AstraZeneca, the British drugmaker reported some encouraging news that could help it expand the use of its clot-fighter Brilinta, once touted as a $3.5 billion-a-year treatment.
The drug, which generated roughly $1.3 billion last year and was one of AstraZeneca’s top ten medicines, was shown in 2017 — as part of a sub-group analysis — 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.
The preceding year, AstraZeneca failed two studies including one in patients with peripheral artery disease, proving no better than aspirin alone in reducing the risk of death, stroke or heart attack, dealing a blow to the drug’s prospects.
On Monday, the company said 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. Detailed data from the 19000-patient Phase III trial, THEMIS, will be provided at a medical meeting.
“The THEMIS trial is the largest randomised trial of patients with type-2 diabetes performed to date and was designed to evaluate whether more-intense antiplatelet therapy is a promising approach. The results could help us refine our understanding of the role of dual antiplatelet therapy in patients across the atherothrombotic spectrum,” said Deepak Bhatt, THEMIS co-chair, executive director of the interventional cardiovascular programs at Brigham and Women’s Hospital and Harvard professor, in a statement.
It is unclear when the Cambridge, UK-based company — whose shares $AZN inched up roughly 0.4% in premarket trading — is planning to file for approval for this patient population.
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