Johnson & Johnson said health regulators denied approval to an expanded use of its blood thinner, Xarelto, to reduce the risk of heart attacks and strokes in patients with acute coronary syndrome.
The drug, which J&J has developed in partnership with German drugmaker Bayer AG, was earlier denied approval in June for the same use, as a panel to the U.S. Food and Drug Administration raised concerns about missing trial data and bleeding risks.
In response to this, J&J submitted to the FDA additional data that showed the benefits and risks of Xarelto in patients who had withdrawn from the study.
"While we saw an increase in major bleeding, there was no increase in fatal bleeding," said Dr. Christopher Nessel, Vice President at Janssen, a unit of J&J.
Xarelto is already approved for six other uses, including reducing the risk of blood clots in patients who have had hip and knee replacement surgery, and to prevent strokes among people with a type of irregular heartbeat called atrial fibrillation.
J&J said on Monday it was evaluating the rejection letter issued by the FDA.
(Reporting By Vrinda Manocha and Zeba Siddiqui in Bangalore. Editing by Andre Grenon)