US Justice Department stops investigation of AstraZeneca's Brilinta trial
- Brilinta (ticagrelor) is used for the treatment of acute coronary syndrome (ACS). Its main competitor product is the generic version of Plavix (clopidogrel).
- The US Department of Justice launched an investigation of AstraZeneca’s 43-country study of Brilinta after hearing allegations of unreported adverse events and deaths during the trial.
- AstraZeneca would like for the Justice Department to make a clear statement about the alleged safety issues in the study, highlighting that the trial was conducted properly and that study results have been reported in accordance with regulatory guidelines.
Brilinta’s revenues have been lower than AZ hoped for, not only because of the aspersions cast on the drug’s safety record in the PLATO trial, but also due to pressure from generic Plavix. Brilinta had just $117 million in sales in Q2 2014.
The main allegations, which were published in the International Journal of Cardiology in 2013, focused on “deficiencies” in reporting PLATO trial results, including the allegation that around 23 definite or possible cardiovascular events or deaths were not properly reported. However, the Justice Department did not find any credence in these claims.
- pharmafile.com Reprieve for AstraZeneca as US drops drug investigation