Reprieve for AstraZeneca as US drops drug investigation
The US Justice department has shelved their controversial investigation into AstraZeneca‘s pivotal clinical trial after finding no wrongdoing has been done.
The inquiry solely focussed on AstraZeneca’s study of the acute coronary syndrome treatment Brilinta, which began in October of last year. Its PLATO (Platelet inhibition and patient outcomes) trial covers the effects of the drug on nearly 19,000 patients across 43 countries. The study was called into question by a medical professor in the US, who subsequently filed a sealed complaint against the trial, this prompted the US Justice Department to start a probe. The US regulators went over the firms data, which had previously approved in 2012 and actually found one patient who was said to dead was actually still alive.
There was also an argument from the International Journal of Cardiology, they argued that an estimated 23 definite or possible cardiovascular events or deaths on Brilinta were also not submitted for adjudication or downgraded to softer options.
The level of criticism and scrutiny for a specific single trial is not a usual step for the Justice Department in particular to take, as they predominately look at the marketing practices of pharma companies once a drug has been approved.
Analysts believed however that the Justice Department would find nothing wrong with AstraZeneca’s data, and now 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.”
Brilinta hasn’t really performed in the market
Brilinta has seen very poor sales, only bringing $117 million in the second quarter of the year, with the target of $2.5 billion in annual sales looking to be a distant dream for the drug that was first approved in Europe in 2011.
With the latest news of the drug getting the all clear, it is now hoped that doctors will start to warm to the drug after initial safety fears have been put to rest. Brilinta hasn’t just been hampered by safety allegations, it has also 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 this includes the US