The US Food and Drug Administration (FDA) has approved BridgeBio Pharma’s Attruby (acoramidis), an oral transthyretin (TTR) stabiliser, to treat adults with transthyretin amyloid cardiomyopathy (ATTR-CM).

Attruby (acoramidis), a near complete TTR stabilizer, has been approved by FDA to reduce cardiovascular death and hospitalization in ATTR-CM patients.

BridgeBio Pharma snagged FDA approval for its rival to Pfizer's heart disease treatment, Vyndaqel. BridgeBio stock catapulted.

The FDA has approved Attruby, a new oral treatment that helps reduce heart-related deaths and hospital visits among adults with transthyretin amyloid cardiomyopathy, or ATTR-CM.

2025 will be a very eventful year for BridgeBio. In addition to the commercial launches of Attruby in the United States, Europe, and Japan, the company expects to report results from registrational trials of infigratinib, encaleret, and BBP-418, and it could have as many as four products on the market by the end of 2026.

BridgeBio Pharma, Inc. BBIO recently announced that it obtained FDA approval for its pipeline candidate acoramidis for the treatment of adults with transthyretin amyloidosis cardiomyopathy (ATTR-CM) to reduce cardiovascular death and cardiovascular-related hospitalization.

The price is close to the average $225,000 annual cost of Pfizer's drugs, before any discounts or rebates, although, BridgeBio has said it will provide Attruby for free for the lifetime of any patient who participated in clinical trials of the drug.

Attruby (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for adults with ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalization. The FDA approval is based on ATTRibute-CM Phase 3 study results,

BridgeBio Pharma Inc. gained US approval for a drug to treat a progressive and deadly form of heart disease, paving the way for the biotech company to go head-to-head with Pfizer Inc. in an increasingly competitive market.