Johnson & Johnson has given the Food and Drug Administration additional data to on its new anticlotting drug, in a second attempt to get approval for more uses.
Xarelto (zah-RELL’toh) is approved for reducing risk of blood clots in people who’ve had knee or hip replacement surgery and reducing stroke risk in people with an irregular heartbeat.
J&J sought approval to market Xarelto for preventing a second heart attack or stroke in patients at high risk because of a narrowed heart artery, and for preventing blood clots from forming around stents, tiny metal-mesh scaffolds that prop open heart arteries.
The FDA turned down one application in June. J&J then withdrew the second. Now it’s sent the FDA data from a huge study showing Xarelto prevented strokes, heart attacks and deaths.