The regulator has approved the company’s heart disease drug Brilinta based on positive data from the phase III THEMIS study.
According to the company, the study demonstrated a statistically significant reduction in the primary composite endpoint of major adverse cardiovascular (CV) events at 36 months with aspirin plus Brilinta 60mg versus aspirin alone in patients with CAD and type-2 diabetes (T2D) at high-risk of a first heart attack or stroke.
It is said to be the first regulatory approval for aspirin plus Brilinta dual antiplatelet therapy in patients who have a high CV risk but without a history of heart attack or stroke.
Brilinta is an oral, reversible and direct-acting P2Y12 receptor antagonist, which works by prohibiting platelet activation.
AstraZeneca-sponsored THEMIS is a multi-national, randomised and double‑blinded phase III study in patients with CAD and T2D with no prior heart attack or stroke.
The company randomised over 19,000 patients in the trial across 42 countries in Europe, Asia, Africa, North and South America.
Regulatory submissions to extend the approved indication for Brilinta based on the THEMIS study are also under regulatory assessment in the EU, Japan, and China.
Recently, the company reported the high-level results from the phase III THALES study, which demonstrated showed aspirin plus Brilinta 90mg reduced the risk of the composite of stroke and death at 30 days after an acute ischaemic stroke or transient ischaemic attack, compared to aspirin alone, said the company.
AstraZeneca biopharmaceuticals business unit executive vice president Ruud Dobber said: “Today’s approval of Brilinta is important news for patients with coronary artery disease who will now have a new therapy option to reduce the risk of a first heart attack or stroke.
“This new indication is a further testament to the overwhelming science supporting Brilinta in the management of patients with coronary artery disease at high risk for cardiovascular events.”
AstraZeneca secured approval for Brilinta in over 110 countries to prevent atherothrombotic events in adult patients with acute coronary syndrome (ACS), while in more than 70 countries for the secondary prevention of CV.
In May, AstraZeneca entered into an agreement with Oxford University for the development of a vaccine to prevent Covid-19 disease.