FRANKFURT, Sept 7 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
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.