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FDA Approves BridgeBio's Attruby (Acoramidis), First Near-Complete TTR Stabilizer for ATTR-CM

Nov 23, 2024, 12:14 AM

BridgeBio Pharma (ticker symbol $BBIO) announced that the U.S. Food and Drug Administration (FDA) has approved Attruby™ (acoramidis), an orally administered near-complete transthyretin (TTR) stabilizer for the treatment of adult patients with transthyretin cardiac amyloidosis (ATTR-CM). Attruby, the first and only approved product specifying near-complete stabilization of TTR (≥90%), was designed to mimic a naturally occurring 'rescue mutation' of the TTR gene (T119M), targeting the root cause of ATTR-CM by preventing destabilization of the native TTR tetramer. The drug is approved to reduce cardiovascular death and cardiovascular-related hospitalization in ATTR-CM patients. The approval sets up competition with Pfizer, which also markets a treatment for ATTR-CM. Attruby will be priced at approximately $245,000 per year.