Amgen defends Tavneos as FDA, European regulators and Japanese doctors raise safety concerns

Amgen said it continues to support its rare-disease therapy Tavneos despite recent safety alerts.

The U.S. FDA has indicated it wants the drug removed from the market after a report of 20 deaths linked to liver toxicity in Japan. European regulators have opened investigations into the integrity of the clinical data.

A Japanese pharmaceutical partner that distributes Tavneos in Japan has advised physicians not to start new prescriptions while the safety issue is reviewed. Amgen has not changed its stance and says it will work with authorities.