BridgeBio Pharma's (BBIO) acoramidis has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, which recommended granting a marketing authorization for the drug to treat wild-type or variant transthyretin amyloidosis in adults with cardiomyopathy, the regulator said Friday.
The CHMP cited a pivotal study that showed treatment with acoramidis, or Beyonttra, reduced cardiovascular hospitalizations over a 30-month period, according to the regulator.
BridgeBio said it expects a final decision from the European Commission "in the coming months" and plans to launch the drug in Europe in H1 2025.
Acoramidis was approved by the US Food and Drug Administration last month as Attruby, BridgeBio added.
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