FDA approves hereditary amyloidosis drug from Akcea, Ionis

Akcea Therapeutics Inc. (NASDAQ:AKCA) said late Friday that 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. ...