BridgeBio Pharma, Inc. (BBIO) announced on Tuesday that the European Commission has granted marketing authorization for BEYONTTRA or acoramidis, the first near-complete TTR stabilizer or =90 percent for the treatment of wild-type or variant transthyretin amyloidosis or ATTR-CM in adult patients with cardiomyopathy.
The approval is based on positive results from the Phase 3 ATTRibute-CM study, where acoramidis showed rapid and significant cardiovascular benefits, including a 42 percent reduction in cardiovascular-related hospitalizations and all-cause mortality after just three months of treatment.
BEYONTTRA is the first and only ATTR-CM treatment in both the U.S. and EU to specify near-complete TTR stabilization, offering patients a new disease-modifying treatment option for this progressive, fatal condition.
Bayer will be responsible for commercialization efforts in the EU, with a launch expected in 2025.
BridgeBio will receive a $75 million milestone payment from Bayer and royalties on future sales of BEYONTTRA in the EU.
The drug is also under review for approval in Japan and Brazil. This approval marks a significant milestone in the treatment of ATTR-CM, providing a breakthrough in patient care and outcomes.
Currently, BBIO is trading at $31.42 down by 1.07%.
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