AZ files Brilinta for secondary prevention use

AstraZeneca’s antiplatelet drug Brilinta has met its objectives in a 21,000-patient Phase III trial that could help the company meet its lofty ambitions for the drug.

Updated results from the PEGASUS-TIMI 54 study – reported over the weekend at the American College of Cardiology (ACC) meeting in San Diego – showed that giving Brilinta (ticagrelor) alongside aspirin reduced major cardiovascular events in patients who had suffered a heart attack between one and three years previously by 15 percent compared to aspirin plus placebo.

The effect on the combined outcome measures of cardiovascular (CV) death, myocardial infarction (MI) or stroke was the same regardless of the dose of Brilinta used – 60mg or 90mg twice daily. However, the higher dose was associated with a significantly higher risk of bleeding episodes and a little under a third of patients discontinued therapy with AZ’s drug over the 33 months of follow-up.

It is the first prospective trial to evaluate longer term dual antiplatelet therapy in higher risk patients with a history of a heart attack, according to AZ.

Brilinta is one of six growth platforms that AZ is counting on to boost its sales to $45bn within the next decade – along with its diabetes and respiratory portfolios, emerging markets, Japan and oncology drugs – and last year the company predicted that it would reach annual sales of $3.5 billion by 2023.

That is a big step up from Brilinta’s $476 million in sales last year. However, the drug is showing signs of accelerated growth – with turnover up 70 percent in 2014 and almost doubling in emerging markets.

That is a dramatic turnaround from the situation a couple of years ago, when AZ faced questions about the reliability of the PLATO clinical trial which underpinned Brilinta’s approval in 2011 as a potential successor to Sanofi’s Plavix (clopidogrel), a former $7 billion-a-year brand that has since succumbed to generic competition.

The US Department of Justice (DoJ) launched a probe into the affair but ruled last year that AZ had no case to answer, lifting the brake on the product’s growth in the US.

Brilinta is currently approved to reduce the rate of thrombotic CV events in patients with acute coronary syndromes (ACS), but a secondary prevention claim on the label could give a sharp boost to the number of patients eligible for treatment with the drug.

“We have just submitted regulatory filings to the European Medicines Agency and the US Food and Drug Administration and we look forward to working with these agencies towards a potential new indication in major markets,” said Elisabeth Björk, who heads AZ’s cardiovascular and metabolic diseases development group.

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