Bayer, J&J clot-drug success lifts U.S. prospects
NEW YORK (Reuters) - A drug being developed by Bayer and Johnson & Johnson has again proven better than a standard treatment in preventing dangerous blood clots among patients undergoing orthopedic surgery, boosting its chances for U.S. approval.
The results were seen in a late-stage trial of the medicine rivaroxaban, or Xarelto, which involved 3,148 patients undergoing knee replacement surgery in the United States and overseas, the companies said on Friday.
"It's confirming the blockbuster potential of the drug. The outcome is better than the non-inferiority that people are expecting," says Ulrich Huwald, an analyst at MM Warburg.
Like three earlier Phase III trials, rivaroxaban proved safe and significantly more effective than Sanofi-Aventis SA's widely used Lovenox, now the gold standard in preventing blood clots among patients recovering from knee- and hip-replacement surgery.
Shares in Bayer rose 1.6 percent to 57.21 euros at 1230 GMT, outshining a 0.7 percent gain in the German DAX index.
"The data tell us we have a true medical advance here because, in consecutive studies, it has showed compelling superiority to a drug that works really well," Peter DiBattiste, J&J's head of cardiovascular medicine, said in an interview.
In the latest trial, patients taking rivaroxaban for 14 days had a 31 percent reduced risk of serious blood clots -- including clots in blood vessels of the leg and of the lung -- and death from all causes compared with patients taking Lovenox for the same period.
The rate of major bleeding, the main safety measure of the trial, was numerically higher for rivaroxaban than Lovenox, but the difference was not statistically significant.
"We had not expected superiority. In that respect, the outcome is all the more positive," Frank Misselwitz, Bayer's head of cardiovascular clinical development, told Reuters.
"We have practically proved superiority against the comparative treatment regime with this fourth study in a row."
PIVOTAL STUDY
Previous large trials pitted once-daily rivaroxaban against the daily 40-milligram dose of Lovenox recommended outside the United States after orthopedic surgery.
The newest study is considered pivotal for the drug's potential U.S. approval because it instead compared rivaroxaban to the overall higher 60 milligram Lovenox doses recommended in the United States -- 30 milligram injections given twice daily.
Results of the latest trial, called Record 4, were presented in Nice, France at the annual meeting of the European Federation of National Associations of Orthopaedics & Traumatology.
"We have deliberately waited for the outcome of Record 4 study before we seek approval from U.S. authorities," Misselwitz said. Continued...
