AP reported that FDA advisers said the benefits of an experimental anticlotting drug from Johnson & Johnson outweigh its risks which include bleeding and incomplete data about liver side effects.
The FDA panel included cardiology experts who voted 15 to 2 in favor of the J & J’s rivaroxaban. If this is approved, it will be “the first new pill-based anticlotting drug in a half-century.”
“J & J and partner Bayer have asked the FDA to clear their once-daily pill to stop blood clots in the legs of patients who have undergone hip or knee replacement surgery.”
This is great news if this new drug can help. However, see our past post: Proposed Drug Rivaroxaban has Bleeding Risk.
Over 800,000 patients in the U.S. undergo the procedures each year. Blood clots are a common side effect and can be deadly if they get loose and travel to the lungs.
FDA is not required to follow the advice these experts and panelists voted on, but “it usually does.”
Rivaroxaban cut the risk of blood clots or death in half in four studies of knee and hip replacement patients as compared with patients taking Sanofi-Aventis’ Lovenox (top selling drug used by orthopedic patients now).
Dr. Peter DiBattiste (J & J’s head of cardiology) said “I think we’re very pleased with the discussion and outcome and look forward to an ongoing dialogue with the agency.”