CHMP announced today the recommendation of Bayer's Xarelto, known generically as rivaroxaban. Xarelto, a blood-thinning pill to prevent clots in patients bedridden after major orthopedic surgery, is being developed jointly with J&J in the U.S. The companies recently announced the results of a study in which rivaroxaban was better than Sanofi's blockbuster Lovenox in preventing venous blood clots in knee replacement patients. The drug is one of Bayer's great pipeline hopes, and could have sales exceeding €2 billion in Europe if approved there.
"The recommendation for approval of rivaroxaban by the CHMP marks another significant milestone in our extensive development program. We received it only nine months after the submission--very fast compared to average," said Dr. Kemal Malik, a member of the Bayer HealthCare Executive Committee. Final approval of the drug is expected in the next several months.