From
The New York Times:
For decades, an anticlotting drug called
warfarin has dominated the market for oral medications used to treat blood clots that form in the veins. Now, there may finally be a new contender.
An advisory panel of the Food and Drug Administration voted on Thursday to recommend that the agency approve a new drug, called rivaroxaban, a joint venture between Bayer Healthcare Pharmaceuticals and Johnson & Johnson.
Johnson & Johnson has applied to the agency for approval to market the drug for short-term use in preventing deep-vein thrombosis and pulmonary embolism in patients undergoing total hip or knee replacement surgery. The agency typically follows the recommendation of such advisory panels composed of outside medical experts.
Industry analysts said the application to temporarily treat orthopedic surgery patients was just a warm-up.
The real money lies in treating millions of chronic patients for stroke prevention and post-acute coronary syndrome, said Rick Wise, an analyst with Leerink Swann.
“This is Act 1 of a multiact play,” said Mr. Wise, who estimated that the orthopedic use of the drug could generate sales of $150 to $200 million annually in the United States. “For Act 2, the prospects look to be much greater.”
Johnson & Johnson has just ended clinical trials of the drug for longer-term use in patients with acute coronary syndrome.
The advent of a challenger to warfarin, the category leader, has the potential to expand sales of drugs to treat thrombosis, or blood clots in veins. Doctors and patients have been looking for an alternative to warfarin because of its significant drawbacks. Common foods and medicines can decrease the efficacy of the drug, requiring patients to have frequent blood tests.
In 2008, Americans spent $304 million on the top three prescription thrombosis drugs, according to data from IMS Health, a health care information company.
But Bruce Nudell, an analyst with UBS Securities, has calculated that a new brand of drug able to supplant warfarin, an inexpensive generic version of which Americans take 1.5 billion doses every year, could eventually generate as much as $6 billion annually.
But the review of rivaroxaban was not without contention.
The drug makers reported that patients in clinical trials who took the pills had half the incidence of blood clots than people who had injections of an anticoagulant drug called enoxaparin. But they also reported that 24 study patients on rivaroxaban subsequently had major bleeding — the kind that can require surgical intervention — compared with 13 who had injections.
An F.D.A. statistician who analyzed the data said the drug was effective. But, because of increased risk of bleeding, the drug did not prove to be superior at preventing life-threatening blood clots or death, she said.
Other large drug companies, including Sanofi-Aventis, Pfizer and other firms are also developing anticlotting medications.