Acoramidis Receives Positive CHMP Opinion for Treatment of Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

• 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 months
  
• Acoramidis, 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 stabilization
  
• In 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 placebo
    
  • A 42% reduction in composite ACM and recurrent CVH events relative to placebo at Month 30
  • A 50% reduction in the cumulative frequency of CVH events relative to placebo at Month 30
    
• Relative increases in serum TTR concentrations resulting from greater TTR stability have been associated with reduced risk of all-cause and cardiovascular mortality in the general population in recent literature¹
  

PALO ALTO, Calif., Dec. 13, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization in the European Union (EU) for acoramidis for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Acoramidis is a selective small molecule, orally administered near-complete (≥90%) transthyretin (TTR) stabilizer. ATTR-CM is a progressive fatal disease that presents as an infiltrative, restrictive cardiomyopathy resulting in heart failure. In the Phase 3 study ATTRibute-CM, acoramidis showed clear benefits on cardiovascular outcomes.