BridgeBio Pharma (BBIO) said Monday that the UK's Medicines and Healthcare Products Regulatory Agency granted marketing authorization for its drug, acoramidis, branded as Beyonttra, for treating transthyretin amyloidosis in adults with cardiomyopathy, including both wild-type and variant forms of the disease.
The company said the approval was based on a phase 3 trial result, where acoramidis significantly reduced cardiovascular hospitalizations, improved survival and preserved patients' physical function and quality of life over 30 months.
Under a partnership formed in 2024, the company said Bayer would handle all UK commercial activities for the drug, and it would receive tiered royalties starting in the low 30% range.
Beyonttra has already been approved in the US, EU, and Japan.
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