FRANKFURT Bayer said its development partner Johnson & Johnson filed a response to U.S. regulators' concerns over a new use for their Xarelto anti-clotting pill to prevent heart attacks and strokes in patients with acute coronary syndrome (ACS).
The U.S. Food and Drug Administration in June declined to approve the new use and issued a so-called complete response letter demanding more information after advisors had expressed concern about bleeding risks.
Patients with ACS have had heart attacks or chest pains that indicate the risk of a heart attack. Their condition is usually caused by blocked coronary arteries and an estimated 1 million people a year in the United States are hospitalized after having an ACS episode.
Bayer also said on Friday it renewed its application for the combined use of Xarelto with standard antiplatelet therapy to reduce the risk of stent thrombosis in patients with ACS.
Xarelto was approved in the United States late last year to prevent strokes among patients with an irregular heartbeat called atrial fibrillation that is most common among the elderly. It is also approved to reduce risk of blood clots in the legs and lungs of people who have had knee or hip replacement surgery.
Xarelto is one of three new medicines that offer potential advantages over older drugs to prevent strokes and other dangerous conditions caused by blood clots.
Investors have tried to bet on which of the three will become dominant in a race between Xarelto, Eliquis from Pfizer Inc and Bristol-Myers Squibb Co, and Pradaxa from private German drugmaker Boehringer Ingelheim.
Pradaxa gained U.S. approval in 2010 for use in atrial fibrillation. Pfizer and Bristol-Myers failed to win approval for Eliquis in June and have been asked to provide further information on the drug.
But Xarelto's rivals failed in treating patients with ACS, and an approval for those patients would have given Bayer and J&J a potentially distinct market.
(Reporting by Ludwig Burger)