FDA Rejects Wider Use Of Xarelto Drug For A Third TimeBy Jaleesa Baulkman, UniversityHerald Reporter
The U.S. Food and Drug Administration have declined - for a third time - to approve proposed expanded use of Bayer AG and Johnson & Johnson's lucrative blood thinning drug, Reuters reported.
The drugmakers of Xarelto, a drug used to reduce dangerous blood clots and related problems in patients with coronary artery disease, sought approval from the U.S. regulators to market the pill for prevention "of new heart attacks and strokes, and death, in patients with acute coronary syndrome (ACS), and also to prevent clogging of heart stents," Reuters reported.
ACS is a complication of coronary heart disease, which is the leading cause of death in the U.S. and one of the most prevalent non-communicable diseases in the world, Johnson & Johnson explained in a news release.
"We remain committed to providing patients who have suffered from acute coronary syndrome with additional protection against stent thrombosis and secondary life-threatening cardiovascular events," Paul Burton, vice president at Janssen Research & Development, the subsidiary of Johnson & Johnson, said in a statement.
The rejection letter was expected after an advisory panel to the FDA unanimously voted against the broader use of the drug last month, stating that too much information was missing "from company studies to accurately gauge Xarelto's benefit," The Associated Press reported.
The federal agency also rejected a second indication to "reduce blood clots in patients who have received a stent, a mesh-metal tube used to open arteries that have been cleared of fatty plaque."
"We are evaluating the contents of the letters and will determine the appropriate next steps," Johnson & Johnson said in a statement.
The drugmakers originally filed for approval of Xarelto to treat patients with ACS in late 2011. The FDA rejected their application, citing missing data. Johnson & Johnson retrieved some missing data but the FDA rejected the drug, prompting J&J to appeal the decision. The FDA denied that appeal.