Acoramidis Receives Positive CHMP Opinion for Treatment of Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
BridgeBio Pharma, Inc. (BBIO)
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Source: GlobeNewswire
The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of acoramidis in the EU based on positive results from the Phase 3 ATTRibute-CM study; final approval decision, typically consistent with the CHMP recommendation, is expected from the European Commission within the coming monthsAcoramidis, a near-complete (=90%) stabilizer of transthyretin (TTR), was approved on November 22, 2024, by the U.S. Food and Drug Administration (FDA) as Attruby™ to reduce cardiovascular death and cardiovascular-related hospitalization in ATTR-CM; Attruby™ is the first and only approved ATTR-CM treatment in the United States that achieves near-complete stabilizationIn ATTRibute-CM, acoramidis demonstrated the most rapid benefit seen in any Phase 3 study of ATTR-CM to date: In as few as 3 months, the time to first event (all-cause mortality (ACM) or cardiovasacular-related hospitalization (CVH)) durably separated relative to placeboA 42% reduction in composite ACM and recur
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