AstraZeneca PLC Says U.S. Authorities End Probe Into Clinical Trial Of Star Heart Drug Brilinta
August 19, 2014
By Mark Terry, BioSpace.com Breaking News Staff
The U.S. Department of Justice announced that it was dropping its 10-month investigation into U.K.-based AstraZeneca’s PLATO clinical trial. The FDA approved the drug Brilinta® in July 2011. Brilinta is an anticlotting medication in a pill form that reduced heart attacks.
However, Victor Serenbruany, an adjunct medical professor at Johns Hopkins Hospital alleged that the study data may have been manipulated. An article in the International Journal of Cardiology, James DiNicolantonio and Ales Tomek, wrote that the FDA’s report on the trial “highlighted what appear to be multiple serious deficiencies in the reporting of the results.” In particular, an analysis of the results found more positive results at test sites monitored by AstraZeneca as opposed to those monitored by an independent clinical research organization. Other physicians and scientists worldwide defended the study. Over 30 sub-analyses articles of the PLATO study have been published since the original publication.
The PLATO study looked at 18,000 patients worldwide with acute coronary syndrome (ACS) to determine if Brilinta was more effective than clopidogrel for the reduction of thrombotic cardiovascular (CV) events, including death. Results of the study indicated a reduction of CV death, myocardial infarction, or stroke compared to clopidogrel. In patients that were treated with percutaneous coronary intervention (PCI), there was a reduction in the rate of stent thrombosis.
Having the investigation dropped is good news for AstraZeneca, which projected sales of Brilinta by 2023 at $3.5 billion. Additional studies of Brilinta have found it effective in other settings. The company is developing a major program to prove these findings with a series of clinical trials projected between 2015 and 2018. Currently the major competing product is Sanofi SA’s Plavix®, which is now off-patent and available as an inexpensive generic.
“It’s frustrating to think of the patients who probably should have been receiving Brilinta for the last nine months but potentially didn’t because of this cloud hanging over the brand,” Tom Keith-Roch said, AstraZeneca’s vice president for the drug. “I think physicians, particularly in the U.S., will now see that a line has been drawn underneath any potential controversy surrounding the trial.”
In more good news, AstraZeneca announced positive results from a Phase III trial that evaluated the investigational antibiotic, ceftazidime-avibactam for treatment for adult hospitalized patients with complicated intra-abdominal infections. The RECLAIM-1 and RECLAIM-2 Phase III studies were jointly evaluated by the U.S. FDA and the European Medicines Agency (EMA). The development of a new antibiotic is particularly good news, given the rarity of new antibiotics.
“As a result of limited available options, infections due to antibiotic resistant Gram-negative bacteria are becoming increasingly more difficult to treat,” said Keith Kaye, MD, professor of Medicine in the division of infectious disease at Wayne State University Hospital in Detroit, Michigan. “New agents are needed and ceftazidime-avibactam could be a welcome addition for physicians who manage high-risk patients with these hard to treat infections.”
