Bridgebio Pharma Says Committee For Medicinal Products For Human Use (CHMP) Recommends Marketing Authorization In European Union For Acoramidis For The Treatment Of Wild-type Or Variant Transthyretin Amyloidosis In Adult Patients With Cardiomyopathy...
Bridgebio Pharma Says Committee For Medicinal Products For Human Use (CHMP) Recommends Marketing Authorization In European Union For Acoramidis For The Treatment Of Wild-type Or Variant Transthyretin Amyloidosis In Adult Patients With Cardiomyopathy...
Bridgebio Pharma Says Committee For Medicinal Products For Human Use (CHMP) Recommends Marketing Authorization In European Union For Acoramidis For The Treatment Of Wild-type Or Variant Transthyretin Amyloidosis In Adult Patients With Cardiomyopathy (ATTR-CM)
BridgeBio Pharma表示，人用药品委员会(CHMP)建议在欧盟中批准Acoramidis用于治疗成人心肌病患者的野生型或变异型转甲状腺素淀粉样变（ATTR-CM）。
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.
人用药品委员会(CHMP)已采纳积极意见，建议在欧盟(EU)中为Acoramidis批准营销授权，以治疗成年心肌病患者的野生型或变异型转甲状腺素淀粉样变(ATTR-CM)。Acoramidis是一种选择性小分子，口服近乎完全(≥90%)稳定转甲状腺素(TTR)。 ATTR-CM是一种进行性致命的疾病，表现为浸润性、限制性心肌病，导致心力衰竭。在III期研究ATTRibute-CM中，Acoramidis对心血管结果显示出明显的益处。