FDA Rejects Proposal to Expand Use of Blood Thinner Xarelto

The US Food and Drug Administration revealed that it has rejected the joint proposal by Johnson & Johnson's and Bayer AG to expand the use of blood thinner product Xarelto for other treatments due to incomplete data.

The FDA had earlier approved the use of Xarelto, brand name for rivaroxaban, in preventing blood clots caused by irregular heartbeat or after a knee replacement surgery while it has also been used in treating and preventing the formation of blood clots.

J&J and Bayer conducted a joint study to test the effectiveness of the drug in preventing heart attacks and strokes and proposed to the FDA that it can be beneficial for patients suffering from acute coronary syndrome (ACS).

The FDA however has rejected the proposal and had said in January that while Xarelto can be an effective treatment option blood clots and stroke prevention, it cannot be used as maintenance or secondary prevention drug, adding that both J&J and Bayer have failed to conclusively prove that it can help heart attacks and strokes from recurring.

Source: Medindia