BUZZ-Amgen up after EMA recommends revoking marketing authorization for rare-disease drug

Amgen Inc.

Amgen Inc.

AMGN

0.00

** Shares of drugmaker Amgen AMGN.O rise 1.2% to $357.2 premarket

** The European Medicines Agency recommended revoking the marketing authorization for Amgen's rare autoimmune disease drug, Tavneos, citing a lack of benefits that outweigh its risks

** In April, the U.S. FDA's Center for Drug Evaluation and Research had proposed withdrawing approval of Tavneos, after identifying 76 cases of drug-induced liver injury with evidence suggesting a causal link to the drug

** Tavneos treats anti-neutrophil cytoplasmic autoantibody-associated vasculitis, a rare group of autoimmune diseases that cause inflammation in small- to medium-sized blood vessels

** In May, about 20 deaths were linked to serious liver dysfunction have been reported in Japan in patients treated with Tavneos, according to a safety notice issued by partner Kissei Pharmaceutical 4547.T

** The FDA earlier this year asked Amgen to voluntarily pull the drug from the U.S. market, but the company declined

** As of last close, stock up 7.8% YTD