Reprieve for AstraZeneca as US drops drug investigation
pharmafile | August 19, 2014 | News story | Sales and Marketing | AstraZeneca, Brilinta, US, blood, justice, plato
The US Justice Department has pulled a controversial investigation into AstraZeneca’s pivotal clinical trial after finding no wrongdoing.
The inquiry was focussed on the UK firm’s study of its acute coronary syndrome treatment Brilinta (ticagrelor) that began in October last year. Its PLATO (Platelet inhibition and patient outcomes) trial covers the effects of the drug on nearly 19,000 patients across 43 countries.
It was called into question by a medical professor in the US who filed a sealed complaint against the trial, prompting the US Justice Department to start a probe.
US regulators went over the firm’s data, which it had approved in 2012, and found at least one patient reported dead who was in fact still alive.
The International Journal of Cardiology also argued last year that an estimated 23 definite or possible cardiovascular events or deaths on Brilinta were also not submitted for adjudication, inactivated, deleted or were downgraded to softer endpoints.
This level of scrutiny for a single clinical trial is an unusual step for the Justice Department in particular, which typically will look only at the marketing practices of pharma companies for drugs once approved.
Analysts believed however that the Justice Department would find nothing wrong with AZ’s data, and today have been proven right.
But it came at a time of continuing medical debate over the PLATO trial, including questions over the more favourable results for the drug in countries where the tests were supervised directly by the company.
Pascal Soriot, the Anglo-Swedish firm’s chief executive, says: “We welcome the Department of Justice’s decision not to pursue further action.
“We have always had absolute confidence in the integrity of the PLATO trial and we are proud of the important benefit Brilinta offers to patients around the world suffering from acute coronary syndrome. As one of AstraZeneca’s growth platforms, we are committed to delivering the full potential of this important medicine.”
Poor sales
The drug has seen a poor sales trajectory as it brought in just $117 million in the second quarter, and looks as if it will not reach the $2.5 billion in annual sales analysts were touting for the medicine when it was first approved for Europe back in 2011.
The company will hope that the Department’s decision will draw some sort of line under the safety issues, at least for now, and help increase uptake among doctors.
But it has not just been these allegations that have hampered revenue, as Brilinta has had to compete with cheaper blood thinners, notably from generic versions of Sanofi/Bristol-Myers Squibb’s Plavix (clopidogrel).
Brilinta is meant to be more favourable than Plavix for certain patients, but data for this have also caused controversy in the medical world.
In a paper in the International Journal of Cardiology published in September last year, the researchers James DiNicolantonio and Ales Tomek highlighted “multiple serious deficiencies in the reporting of PLATO results”.
They showed results for Brilinta were more favourable than Plavix in countries where the Plato study was supervised by AstraZeneca, rather than by a third-party contract research organisation (including the US).
Ben Adams
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