China - Bayer expects China approval for stroke drug Xarelto

Germany's largest drugmaker, Bayer AG, expects to obtain approval within two years from China to expand the uses for its anti-clotting drug Xarelto to include stroke prevention.

Xarelto is one of three new anti-blood clotting pills expected to replace the decades-old and problematic stroke preventer Warfarin. The other two are Boehringer Ingelheim's Pradaxa, and Eliquis, developed by Bristol-Myers Squibb and Pfizer.

Xarelto has already won approvals from the United States, European Union, Malaysia and Japan for use to prevent stroke in patients with atrial fibrillation, or an irregular heartbeat.

Approvals from other countries are expected in coming months, said Richard Nieman, Bayer's vice president and head of global medical affairs in Asia.

Bayer has said it expects more than 2 billion euros ($2.7 billion) in peak annual sales from the product, which Bayer co-developed with Johnson & Johnson.

"For this year, we expect the bulk of approvals...in the next year or so. We absolutely expect approval in China," Nieman said in an interview in Singapore. Nieman said the company expects the drug to sell well because "cardiovascular disease is on the rise in Asia and it is under-diagnosed."

One out of every five deaths in China is now due to stroke, with other major causes of death being cancer, respiratory and heart-related diseases, according to China's health ministry.

Xarelto, which uses the active ingredient rivaroxaban, is approved in more than 110 countries, including China, to fight deep-vein thrombosis in patients undergoing hip or knee surgery.

Reuters

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