CDER proposes to withdraw approval of TAVNEOS

https://www.fda.gov/drugs/drug-alerts-and-statements/cder-proposes-withdraw-approval-tavneos?utm_campaign=the_readout&utm_medium=email&_hsenc=p2ANqtz--m4nog35JuJZcCMgyApFzA7kjrbIX8u-kfc8y4tpdgP8VKGf0eUA969r4mHBM7v21MYCkiH6V6z1fsJP0G3UD7sifGfQ&_hsmi=419253004&utm_content=416113426&utm_source=hs_email 20 deaths linked to Amgen's Tavneos in Japan Alarm is growing around Amgen’s rare disease drug Tavneos after partner Kissei Pharmaceutical disclosed roughly 20 deaths linked to serious liver dysfunction in Japan, the Wall Street Journal writes. The company told doctors to stop prescribing the drug to new patients and reevaluate those already taking it, warning that many severe liver injuries showed up within three months of treatment. Some cases involved a devastating condition that destroys bile ducts. About 8,500 patients in Japan have received Tavneos since its 2022 launch. The drug treats ANCA-associated vasculitis, a rare autoimmune disease that inflames blood vessels. Earlier this year, the FDA asked Amgen to voluntarily pull the drug from the U.S. market over liver safety concerns. Amgen refused, arguing the drug still has a favorable benefit-risk profile. https://www.wsj.com/health/pharma/20-people-in-japan-died-after-taking-amgen-drug-40edaefd?utm_campaign=the_readout&utm_medium=email&_hsenc=p2ANqtz-8PQ1jBI30ZsD-IeH9ADdpLKYOtZ6XNWBRUDIjFO28zXTx3EukUjUDBSQAiBnjUCAaEmBW55nGAZYOI6qfrIxP2nWWtug&_hsmi=419253004&utm_content=419253004&utm_source=hs_email