Bayer AG shares have been buoyed by US approval for its key anti-clotting drug Xarelto, after earlier investor fears the medicine might be delayed or restricted in the world’s most important market.
The US Food and Drug Administration’s green light for Xarelto as a first-line treatment countered expectations it would only be available for patients who were not able to take older therapies.
Xarelto, which was co-developed with Johnson & Johnson, is the second new oral anticoagulant after Boehringer Ingelheim’s Pradaxa to be approved for stroke prevention in patients with a common heart rhythm disorder known as atrial fibrillation.
Both drugs are designed to replace decades-old warfarin, which requires regular blood monitoring and is notoriously difficult to use.
Analysts at brokerage Jefferies said the US approval was a positive surprise given doubts about the product following negative comments earlier this year from FDA staff reviewing Xarelto.
Bayer shares were 4,7% higher at 46,99 euros by 10:10 SA time, after touching 47,15, while the European drugs sector was down 0,8%.
The market to replace warfarin is estimated to be worth more than $10 billion in annual sales. However, the favourite to win the lion’s share of business is neither Xarelto or Pradaxa but a third drug, Eliquis, that has yet to be approved.
Bristol-Myers Squibb’s and Pfizer’s Eliquis is tipped to emerge as the leader of the pack because it has so far shown the best clinical data, especially for reducing the risk of major bleeding.
Bayer has said it expects more than 2 billion euros ($2,7 billion) in peak annual sales from Xarelto.
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