BioCentury
ARTICLE | Clinical News

FDA approves hereditary amyloidosis drug from Akcea, Ionis

October 12, 2018 5:27 PM UTC

Akcea Therapeutics Inc. (NASDAQ:AKCA) said FDA approved Tegsedi inotersen (IONIS-TTRRx) to treat polyneuropathy of hereditary transthyretin (TTR) amyloidosis (hATTR).

Tegsedi's label includes a black box warning of increased risk for thrombocytopenia and glomerulonephritis. It also comes with a REMs requiring patients to receive platelet monitoring at least weekly...