UPDATE 1-Bayer, J&J's Xarelto gets FDA priority review
FRANKFURT, July 9 (Reuters) - 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.
- Sunken Korea ferry relatives give DNA swabs to help identify dead |
- Special Report: How the U.S. made its Putin problem worse
- Vice-principal of South Korea school in ferry disaster commits suicide |
- Death toll climbs to at least 13 in worst tragedy on Everest |
- Mediator heads to east Ukraine, seeking surrenders |