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

Kissei Pharmaceutical Co

Yesterday 12:23

** 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 


 (Reporting by Siddhi Mahatole)
 ((siddhi.mahatole@thomsonreuters.com))