FDA Rejects Wider Use of Blood Clot Prevention Drug
The U.S Food and Drug Administration (FDA) has decided again to decline approval for a proposed wider usage of Xarelto, a potential blood clot preventer manufactured by Bayer AG and Johnson & Johnson.
The two companies were seeking approval from the FDA for the second time for the prevention of new heart attacks, strokes, and death in patients with acute coronary system (ACS). Another use would be to prevent the clogging of heart stents.
According to Reuters, ACS is an “umbrella term covering any condition brought on by sudden reduced blood flow to the heart, including heart attack and chest pain.”
Xarelto can currently be used to prevent strokes and blood clots in patients with an irregular heartbeat called atrial fibrillation, a condition which occurs mainly in the elderly. However, this past January, an advisory panel to the FDA decided that the drug should not be approved to prevent new strokes or heart attacks, a use referred to as secondary prevention.
Reasons behind the Multiple Rejections
The initial panel mentioned above found that the clinical data from the single J&J trial was not sufficient enough to justify the approval of the drug.
The approval for Xarelto in ACS was first filed in late 2011. The FDA rejected it, citing missing data. Once the company retrieved the data, the FDA again declined the approval, leading to the decision to be appealed by J&J.
The FDA then denied the appeal, leading to J&J revising their marketing application. The panelists decided that the additional data provided did not change their view that the drug's benefits did not outweigh an increased risk of bleeding.
Kristina Chang, spokeswoman for Johnson & Johnson, declined to comment when asked if the FDA requested new clinical trials.