Breaking News: Acoramidis Receives Green Light from CHMP for Revolutionary Treatment of Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
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.
This groundbreaking news brings hope to the community of patients suffering from transthyretin amyloid cardiomyopathy (ATTR-CM). Acoramidis, the revolutionary treatment, has received a positive recommendation from the CHMP, marking a significant milestone in the fight against this debilitating disease.
Transthyretin amyloid cardiomyopathy is a severe condition that affects the heart, leading to progressive heart failure and ultimately, a fatal outcome. For years, patients diagnosed with ATTR-CM have faced limited treatment options and a poor prognosis. However, with the introduction of acoramidis, there is newfound optimism in the medical community.
The Phase 3 study ATTRibute-CM demonstrated the efficacy and safety of acoramidis in improving cardiovascular outcomes for patients with ATTR-CM. The near-complete stabilization of transthyretin (TTR) offered by acoramidis presents a promising avenue for managing and potentially halting the progression of this devastating disease.
As we look towards the future, the approval of acoramidis in the European Union heralds a new era in the treatment of transthyretin amyloid cardiomyopathy. Patients and healthcare providers can now embrace a novel therapeutic approach that has the potential to transform the lives of those affected by this condition.
How will this affect me?
As a patient diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM), the approval of acoramidis offers a beacon of hope in your treatment journey. With the availability of this revolutionary medication, there is an opportunity for improved cardiovascular outcomes and a better quality of life. Consult with your healthcare provider to explore the potential benefits of acoramidis in managing your condition.
How will this affect the world?
The approval of acoramidis for the treatment of transthyretin amyloid cardiomyopathy marks a significant advancement in the field of cardiology and genetic diseases. With the introduction of this innovative therapy, the medical community gains a valuable tool in combating a progressive and fatal condition. The positive impact of acoramidis extends beyond individual patients to contribute to the global fight against cardiovascular diseases.
Conclusion
In conclusion, the CHMP’s positive opinion recommending marketing authorization for acoramidis signifies a major breakthrough in the treatment of transthyretin amyloid cardiomyopathy. This revolutionary medication offers hope and promise to patients with ATTR-CM, providing a new avenue for managing the disease and improving cardiovascular outcomes. The approval of acoramidis not only benefits individuals facing this challenging condition but also represents a significant milestone in advancing healthcare innovation on a global scale.