Xarelto group questions for the prevention of stroke
(Reuters) - A U.S. consumer group said the use of Xarelto, a drug used to prevent blood clots after orthopedic surgery, should not be broadened to include prevention of stroke due to its safety and effectiveness is uncertain.
The advocacy group Public Citizen consumer, said in a letter to the Food and Drug Administration on Thursday that two drugs shown to already exist to treat the condition.
The FDA plans to decide early November, the possibility of extending the use of the drug, marketed by Johnson & Johnson and Bayer AG.
Last month, FDA reviewers said that for conditions such as stroke, which can cause irreversible damage, new drugs must be shown to be at least as effective as older treatments, and called the agency to delay approval of Xarelto is.
However, a panel of FDA advisers subsequently voted to recommend approval.
Public Citizen said Xarelto, also known as rivaroxaban, may cause a rebound phenomenon of shock when the medication is discontinued. The group also said the drug trials were conducted in a manner that favored Xarelto.
Bayer has said it expects more than 2 million euros (2.7 billion) in peak annual sales of the product.
Xarelto is one of three new anti-blood clotting pill expected to replace the decades-old, and potentially dangerous, warfarin stroke prevention.
Analysts estimate that the total annual market for these oral medications to be as high as $ 20 billion.
Boehringer Ingelheim pairs listed in August won European marketing authorization of rival pill Pradaxa stroke prevention, defending his lead over Bayer in one of the most promising classes of medicine.
Another treatment is Eliquis rival, being developed by Bristol-Myers Squibb and Pfizer Inc.
Xarelto group questions for the prevention of stroke
