Amgen's Tavneos Drug Gets New Japan Warnings After 20 Deaths; US FDA Withdrawal Looms
AMGN sits 24% above its 52-week low of $267.83.
Summary
Amgen's rare-disease drug Tavneos (avacopan) has received new warnings in Japan from the Ministry of Health following 20 patient deaths attributed to liver injuries. Amgen's licensee, Kissei Pharmaceutical, reversed its prior recommendation to halt prescriptions, but doctors are now advised to carefully monitor patients' liver function. This follows the May 15th news of Kissei instructing doctors to stop prescribing the drug. The article also highlights the FDA's move in April to formally withdraw approval for avacopan in the U.S., citing concerns over manipulated clinical data. These regulatory actions and patient deaths represent a significant challenge for a drug Amgen acquired for $3.7 billion, impacting its sales potential and Amgen's reputation.
At the time of this announcement, AMGN was trading at $330.90 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $179B. The 52-week trading range was $267.83 to $391.29. This news item was assessed with negative market sentiment and an importance score of 9 out of 10. Source: Dow Jones Newswires.