The European Medicines Agency has contacted AstraZeneca asking the company to provide more information about a U.S. probe into a clinical trial of the company’s new blood thinner Brilinta (ticagrelor), reports Reuters.
On November 7 EMA said that it contacted AstraZeneca earlier after the U.S. Department of Justice probe was disclosed by the company on October 31. “The EMA takes seriously any information that may have an impact on the profile of a drug’s benefits and risks. At the moment we are at the point of trying to understand what is going on,” said EMA spokeswoman Monika Benstetter to Reuters.
In AstraZeneca’s latest interim-report it appeared that the U.S. Department of Justice is to initiate an investigation of Brilinta, however no further details were disclosed on the matter.
In 2011, a study involving 18 000 patients gave a green light for AstraZeneca to launch Brilinta.