AstraZeneca gains fast-track review for Brilinta

The US FDA has granted AstraZeneca’s (AZ) Brilinta a priority review for patients with a history of heart attack.

The announcement is good news for AZ, which has identified Brilinta (ticagrelor) as one of its platforms for growth and, if approved, the licence could significantly expand its use.

The company wants to see Brilinta used for up to three years to prevent people having a second heart attack. The FDA is due to make its decision in the third quarter of this year. Its decision on whether to grant this long-term use, or a shorter duration, will have a direct impact on its future revenues.

The drug hit sales of $476 million in 2014, up an impressive 68 per cent on 2013. In the first quarter of this year, it achieved a 45 per cent increase in revenues.

The company says the drug can hit peak sales of $3 billion, although analysts are yet to be convinced it can scale these heights.

AZ’s supplemental new drug application (sNDA) is based on results from the PEGASUS-TIMI 54 study, a large-scale outcomes trial in more than 21,000 patients that investigated Brilinta tablets plus low dose aspirin, compared to placebo plus low dose aspirin, for the chronic secondary prevention of atherothrombotic events in patients who had experienced a heart attack one to three years prior to study enrolment.

Elisabeth Björk, vice president, head of Cardiovascular and Metabolic Diseases, Global Medicines Development, said: “Recent research has shown that one in five patients will have a further heart attack, stroke or cardiovascular death in the subsequent three years following a heart attack, even if they are event free after the first 12 months.

She added that there was a clear need for new options beyond aspirin, (the current standard of care) for the long-term prevention of heart attacks and strokes in patients with a history of heart attacks.

However the case for long-term use of the drug is not overwhelming. The PEGASUS study showed the drug cut the risk of cardiovascular death, stroke and heart attack by 15-16 per cent, but absolute risk reduction was much smaller. There was also a higher risk of bleeding in patients taking Brilinta compared to placebo.

The New England Journal of Medicine published the PEGASUS study and in its editorial commentary called the risk-benefit analysis ‘close to an even proposition’, saying the prevention numbers were offset by the risks of bleeding.

AZ has further trials assessing Brilinta for the prevention of cardiovascular events in patients with peripheral arterial disease, ischaemic stroke or transient ischaemic attack, and in patients with diabetes and coronary atherosclerosis.

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