BridgeBio’s Acoramidis Approved in Japan for ATTR-CM Treatment

BridgeBio Pharma, Inc. (Nasdaq: BBIO) has announced that the Japanese Ministry of Health, Labour and Welfare has approved acoramidis, branded as Beyonttra, for the treatment of transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). This approval provides a new treatment option for Japanese patients suffering from this progressive and fatal disease.

Acoramidis is an orally administered small molecule that stabilizes transthyretin (TTR) with near-complete (≥90%) effectiveness. Increased TTR stability has been linked to reduced all-cause and cardiovascular mortality. The approval is based on positive results from Alexion, AstraZeneca Rare Disease’s Phase 3 study in Japan, as well as BridgeBio’s global ATTRibute-CM Phase 3 trial, which demonstrated a 42% reduction in mortality and cardiovascular hospitalization events compared to placebo at Month 30.

Alexion, AstraZeneca Rare Disease, holds exclusive rights to commercialize Beyonttra in Japan and plans to launch it in the first half of 2025. As part of the agreement, BridgeBio will receive a $30 million milestone payment and royalties in the low double digits on Japanese sales.