19th Aug 2014 06:51
LONDON (Alliance News) - AstraZeneca PLC Tuesday said that the US Department of Justice has closed a probe into a clinical trial involving anti-clotting drug Brilinta and won't be taking further action, as it also reported that antibiotic ceftazidime-avibactam hit the targets in late-stage trials into its potential use against intra-abdominal infections.
The so-called PLATO trial for Brilinta was an outcome study comparing the drug as a treatment with aspirin against clopidogrel plus aspirin. It was established to see whether Brilinta plus aspirin could achieve a meaningful reduction in cardiovascular events like heart attacks in acute coronary syndrome patients, above and beyond that afforded by clopidogrel plus aspirin. It involved 18,624 patients in 43 countries.
The results were favourable for Brilinta plus aspirin, and the drug was approved as a treatment for patients with acute coronary syndrome.
However, the drug trial was called into question by a specialist medical professor in the US, who filed a sealed complaint against the trial, prompting the US DOJ to last year start a probe.
"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," AstraZeneca Chief Executive Pascal Soriot said in a statement Tuesday.
The company is currently putting Brilinta through another trial to test whether it could be used as a treatment in patients who have suffered an acute ischemic stroke, as well as a separate trial for its use as a treatment in Type 2 diabetes and coronary atherosclerosis, or coronary artery disease.
Separately, AstraZeneca said two phase III trials investigating the potential of the antibiotic ceftazidime-avibactam as a treatment for hospitalised adult patients with complicated intra-abdominal infections had met their targets.
The drug is being developed to treat bacterial infections which are becoming resistant to antibiotics.
The RECLAIM-1 and RECLAIM-2 Phase III studies both evaluated the safety and efficacy of the drug administered intravenously as a two hour infusion plus metronidazole, compared to meropenem, administered intravenously as a 30 minute infusion. Ceftazidime-avibactam met the objective of statistical non-inferiority compared to meropenem, AstraZeneca said.
The adverse event rate for CAZ-AVI in combination with metronidazole was similar to meropenem, the company said. The most commonly reported adverse events for CAZ-AVI in combination with metronidazole were diarrhoea, nausea, vomiting and fever, "which were not unexpected based on the known safety profiles of ceftazidime and metronidazole".
By Steve McGrath; [email protected]; @stevemcgrath1
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