FRANKFURT, July 9 Bayer and Johnson &
Johnson's anti-blood-clotting pill Xarelto won priority
review status from the U.S. Food and Drug Administration for the
treatment of deep vein thrombosis and pulmonary embolism.
The priority review also includes the drug's use in the
long-term prevention of venous thromboembolism in patients who
have already suffered an attack, the German drugmaker and its
U.S. partner said on Monday.
Thromboembolism is the clogging up of veins, typically in
the leg, which is a major risk for bed-ridden or immobile
patients. If such a blood clot dislodges and travels to the
lungs, it can cause potentially deadly pulmonary embolism,
meaning parts of the lungs get cut off from blood supplies.
An FDA priority review takes six months rather than the
usual 10 to 12-months.
Bayer also said it would for now withdraw its request for
FDA approval of using Xarelto to cut risk of blood clots
developing in heart stents. The request was filed on May 9.
The move is linked to a separate request, which it had been
forced to rework.
U.S. regulators last month declined to approve a new use for
Xarelto to reduce the risk of heart attacks and strokes in
patients with acute coronary syndrome, and Bayer and J&J are now
working on a renewed application that will also include the use
for stent patients.
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.
Pfizer Inc and Bristol-Myers Squibb Co's
Eliquis and private German drugmaker Boehringer Ingelheim's
Pradaxa are the other drugs.
Stroke prevention in patients with a form of irregular heart
beat common among the elderly represents by far the biggest
commercial opportunity for the new drugs, which were designed to
replace decades-old heart pill warfarin.