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BridgeBio ' s的甲状腺素转淀粉样变性治疗获得欧盟批准
2025-02-11 23:58
- BridgeBio Pharma (NASDAQ:BBIO) announced that the European Commission has granted marketing authorization for acoramidis, sold under the brand name BEYONTTRA, in the European Union.
- It is approved for treating adult patients with wild-type or variant transthyretin amyloidosis with cardiomyopathy.
- The EU approval is based on the results of the pivotal ATTRibute-CM Phase 3 study, which demonstrated significant benefits for cardiovascular outcomes.
- Following this approval, Bayer plans to launch acoramidis in the first half of 2025.
- The drug is also under review by the Japanese Pharmaceuticals and Medical Devices Agency and the Brazilian Health Regulatory Agency.
- Source: Press Release
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