LEVERKUSEN (dpa-AFX) - BridgeBio Pharma (BBIO) announced the Committee for Medicinal Products for Human Use or CHMP has adopted a positive opinion recommending marketing authorization for acoramidis for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy. The final approval decision is expected from the European Commission in the coming months. Acoramidis was approved by the FDA on November 22, 2024.
Since March 2024, BridgeBio and Bayer have pursued a collaboration for acoramidis. BridgeBio holds the marketing rights for acoramidis in the U.S., while Bayer holds the marketing rights in Europe. Pending European Commission approval, Bayer plans to launch acoramidis in Europe in the first half of 2025.
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