Matthew Perrone, AP
Johnson & Johnson annouced that U.S. regulators have approved its new blood thinner, which is shown to reduce deadly blood clots in patients who have undergone knee and hip replacements. The Food and Drug Administration decision makes rivaroxaban the first U.S.-approved drug that works by blocking a clotting protein called factor Xa. That's in contrast to older blood thinners that work by preventing platelets from sticking together.
The once-a-day pill will serve as an alternative to the popular injection Lovenox, which is the standard treatment for patients who have undergone orthopedic surgery. Rivaroxaban had greater efficacy than Lovenox in head-to-head trials, and similar rates of side effects such as major internal bleeding. J&J said its new drug would be priced similarly to Lovenox, which is marketed by French drugmaker Sanofi-Aventis SA. More than 800,000 knee and hip replacement surgeries are performed in the U.S. each year, causing inflammation in the leg tissue and preventing patients from walking for extended periods of time.
"The combination of tissue damage and immobility can lead to large blood clots in the legs, which can break off and travel to the lungs," said Dr. Paul Chang, vice president of J&J's Jansen Pharmaceuticals unit. J&J first filed its application for rivaroxaban in July 2008, but in May 2009 the FDA delayed making a decision on the drug after raising concerns about internal bleeding risk. The drug's label will carry a warning about that side effect as well as itching, muscle pain, blisters and fainting.
Rivaroxaban was discovered by German drugmaker Bayer Healthcare, which already markets the drug in 110 countries around the world. New Brunswick, N.J.-based J&J will market the drug in the U.S. under the brand name Xarelto. While the decision is an important step for J&J, the larger market opportunity for the drug is in treating patients with irregular heartbeats caused by atrial fibrillation. The FDA is due to rule on that use in November.