A Food and Drug Administration advisory panel voted on Thursday to recommend that the agency approve a new drug called rivaroxaban for short-term se in preventing deep-vein thrombosis and pulmonary embolism in patients undergoing total hip and knee replacement surgery.

 

Rivaroxaban,a joint venture between German drugmaker Bayer AG and Johnson & Johnson,  is already sold under the brand name Xarelto in Europe.

“We are very pleased that the advisory committee has voted in support of the risk-benefit profile of rivaroxaban shown in our studies," said Peter DiBattiste, vice president, Johnson & Johnson pharmaceutical research and development.

 

If approved by the FDA, rivaroxaban would provide competition for the anticlotting medication warfarin, which has long had a hold on the market for oral drugs that treat blood clots in the veins.

 

Although the drug proved generally effective in reducing blood clots, it still had side effects. To be more specific, 24 study patients taking rivaroxaban subsequently had major bleeding – the kind that can require surgical intervention – compared with 13 who had injections.

 

More than 800,000 people have total knee or hip replacement surgery annually. A common side effect of the surgeries is blood clots that can kill if they travel to the lungs. If approved, rivaroxaban would benefit all these people.

 

The FDA is expected to make a decision on whether to approve the medication by May 28. If approved, Bayer would receive a royalty as high as 30 percent on US sales, under an agreement with J&J.