Johnson & Johnson (JNJ) and its partner Bayer AG (BAYN) suffered a blow when FDA rejected for the second time the extended use of Xarelto, a blood thinner, to treat heart disease and reduce the risk of heart attacks.
Xarelto is an approved drug to prevent blood clots in patients undergoing hip and knee surgeries and to prevent stroke in patients with irregular heartbeats.
Earlier in July 2012, FDA had denied the approval to use Xarelto on heart patients stating missing data of around 1000 patients towards the end of the study.
On tracking down the data from patients who withdrew from the study, the overall results were positive. The drug when used with other regular drugs had the efficiency to reduce the risk of death due to heart disease by 16%.
However, the risk of bleeding increased by nearly four times, which outweighed the efficacy of Xarelto in preventing heart attacks. This has greatly influenced FDA's decision to reject the blood thinner to treat heart patients.