FDA Approves New Anticlot Drug From J&J And Bayer
Written on June 30, 2011 by Maragaret Harrison
–Xarelto enters competitive but potentially large market for new anticoagulants
–FDA approves Xarelto after 2-year delay in which it sought more information
–J&J to charge $6.75 per day of treatment
The U.S. Food and Drug Administration approved a new drug to prevent blood clots that was co-developed by Johnson & Johnson and Bayer AG .
The clearance of the anticoagulant Xarelto is the latest development in an emerging battle among major drug companies including Pfizer Inc. over what is expected to become a multibillion-dollar market for new blood thinners treating cardiovascular conditions, which may replace older drugs, including warfarin.
Xarelto has been available in Europe since 2008, but the FDA in 2009 declined to approve it because the agency wanted more information. J&J said in January it submitted the requested information, clearing the way for the FDA’s green light.
On Friday, J&J and Bayer said the FDA approved Xarelto to prevent certain blood clots, known as venous thromboembolism, or VTE, in people undergoing knee- and hip-replacement surgery. Xarelto also is known by the generic name for its active ingredient, rivaroxaban.
J&J said Xarelto is the first new oral anticoagulant approved to prevent VTE in joint-replacement surgeries in the U.S. An older drug used for this purpose, enoxaparin, is injected.
The wholesale acquisition cost for Xarelto will be $6.75 per day, said Paul Chang, vice president of medical affairs for internal medicine at J&J’s Janssen Pharmaceuticals unit.
While the FDA’s green light is a victory for J&J and Bayer, they are hoping for additional regulatory approvals for more uses of the drug that are crucial to Xarelto’s market success.
A bigger market for Xarelto and other similar blood thinners lies in their use to prevent strokes in people with a heart-rhythm disorder called atrial fibrillation. J&J and Bayer have filed applications to European and U.S. regulators for approval to market Xarelto for this use, and decisions could come later this year.
J&J will primarily handle commercialization of Xarelto in the U.S., with support from Bayer’s sales force. Bayer handles marketing of the drug outside the U.S.
Xarelto enters a competitive market. Last year, the FDA approved Boehringer Ingelheim’s Pradaxa blood thinner to prevent strokes in atrial fibrillation. Pradaxa is a so-called direct-thrombin inhibitor, a different mechanism than Xarelto, but it’s also taken orally and is intended for similar uses.
Xarelto belongs to class of drugs known as Factor Xa inhibitors. Pfizer and Bristol-Myers Squibb Co. have co-developed another Factor Xa, apixaban. Last week, they released limited results of a clinical trial that some analysts interpreted as suggesting that apixaban was superior to Xarelto, though the drugs weren’t compared head-to-head.
Xarelto, however, now has the advantage of beating apixaban to the U.S. market, as well as a once-daily dosing regimen, versus twice daily for apixaban.
J&J’s Chang said it was premature to conclude that apixaban has the upper hand over Xarelto. “We really don’t know much about the results of the apixaban study,” he said. “We need to see the full presentation and understand the data.”
Daiichi Sankyo Co. has developed another Factor Xa inhibitor, edoxaban, which has been approved in Japan.
Adverse events associated with Xarelto in clinical studies included bleeding.
Barclays Capital estimates the so-called warfarin-replacement market will reach $12 billion by 2020; others have put the market as high as $20 billion or more.
For J&J, Friday’s news marks the latest new drug approval for the New Brunswick, N.J., giant health products company. Among the new therapies gaining clearance recently are prostate-cancer treatment Zytiga and HIV drug Edurant. J&J’s new drugs could add $6 billion in sales by 2015, some analysts say.
J&J shares rose 1.2% to $67.30 Friday.
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