Europe’s drug regulator just issued a letter to AstraZeneca requesting more data on a United States investigation into a clinical trial of its new cardiac medication, Brilinta.
According to a recent Reuters report, the drug maker has high hopes that Brilinta will bring in near-term sales and profit growth. The probe, launched by the U.S. Department of Justice (DOJ) is considered unusual and has raised concerns about the medication.
The European Medicines Agency (EMA) just announced that it contacted AstraZeneca—Great Britain’s second-largest drug maker—earlier this week, following a disclosure about the U.S. probe on October 31st, according to Reuters. “The EMA takes seriously any information that may have an impact on the profile of a drug’s benefits and risks,” spokeswoman Monika Benstetter told Reuters. “At the moment, we are at the point of trying to understand what is going on,” she added.
AstraZeneca disclosed the matter in its third-quarter 2013 earnings release, The Wall Street Journal reported. The drug maker indicated that it will “cooperate with the inquiry.”
The study that resulted in marketing approval in 2011 involved 18,000 patients, yet has been criticized by medical experts over the way in which it was conducted, Reuters reported. Ayesha Bharmal, a spokeswoman for AstraZeneca told Reuters that the drug firm advised the EMA and other regulators of the DOJ’s civil investigative demand, saying that she could not provide any other comments.
Launched two years ago, Brilinta sales have not been as high as expected; however, AstraZeneca has increased marketing efforts and is hoping that additional clinical tests will highlight its heart attack prevention benefits, Reuters reported. Last week, Pascal Soriot, the CEO of AstraZeneca, said the he was “very confident” in the pivotal clinical trial’s—PLATO—findings, adding that PLATO was led by “a strong academic group.”
Neither AstraZeneca nor the DOJ have released any information on the exact nature of the probe; however, analysts believe the investigation may concern some parts of the study that have garnered external researcher criticism, according to Reuters.
For example, Reuters reported that James DiNicolantonio of Ithaca New York and Ales Tomek of Charles University in Prague, indicated in a recent paper that patients involved in the trial that was overseen by AstraZeneca were reported as receiving greater benefit from Brilinta than those patients whose treatment with Brilinta was monitored by an independent clinical research organization.
Bernstein analyst Tim Anderson stated in a research note this week that AstraZeneca could suffer a “material downside” if the Justice Department’s probe unearthed serious study flaws, Reuters indicated.