The Japanese Ministry of Health, Labour and Welfare on Thursday approved BridgeBio Pharma, Inc. ( BBIO )‘s acoramidis, under the brand name Beyonttra, for adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM).

Acoramidis is a selective small molecule, orally administered, near-complete (≥90%) transthyretin (TTR) stabilizer.

ATTR-CM is a progressive, fatal disease that presents as an infiltrative, restrictive cardiomyopathy, resulting in heart failure.

AstraZeneca Plc ( AZN )‘s Alexion will be responsible for all commercial activity for Beyonttra in Japan.

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The approval in Japan is based on results from a Phase 3 open-label, single-arm study conducted in Japan by Alexion, AstraZeneca Rare Disease, and the global ATTRibute-CM Phase 3 study.

In the Japanese trial, acoramidis was generally well tolerated, and 0% mortality was reported during the 30-month acoramidis treatment period.

BridgeBio’s global ATTRibute-CM Phase 3 trial showed early separation at 3 months in time to the first event (all-cause mortality or cardiovascular-related hospitalization ACM or CVH) durably separated relative to placebo.

Furthermore, in the global ATTRibute-CM trial, acoramidis led to a 42% reduction in composite ACM and recurrent CVH events relative to placebo at Month 30 and a 50% reduction in the cumulative frequency of CVH events relative to placebo at Month 30.

Based on the terms of the agreement, BridgeBio will receive a $30 million milestone payment upon approval in Japan, as well as royalties in the low double digits on sales of acoramidis in Japan, with commercialization efforts planned in the first half of 2025.

Price Action: BBIO stock is up 1.6% at $36.70 at the last check Thursday.

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