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PALO ALTO, Calif. – The FDA has approved BridgeBio Pharma's new drug, Attruby (acoramidis), as a treatment for adults with transthyretin amyloid cardiomyopathy (ATTR-CM).
The approval is based on positive results from a Phase 3 clinical trial involving over 600 patients. The study showed that the drug significantly improved patient outcomes, reducing hospital visits and enhancing quality of life.
This condition is a progressive and life-threatening heart disease caused by the destabilization of the protein transthyretin (TTR). Attruby works by stabilizing the TTR protein to prevent its breakdown, which helps reduce cardiovascular deaths and hospitalizations. Attruby is notable for being the first approved medication specifically designed to achieve near-complete stabilization of TTR, addressing the underlying cause of ATTR-CM.
BridgeBio is also seeking regulatory approval in Europe, with a decision expected in 2025. The company has partnered with Bayer to commercialize the drug in European markets. Additionally, BridgeBio has committed to providing free medication to participants in its clinical trials.
While Attruby presents a promising treatment option, analysts note it faces competition from existing drugs, like Pfizer's tafamidis, which emphasizes benefits for overall mortality. Despite this, the approval of Attruby marks a significant advancement in the treatment of ATTR-CM, offering new hope to patients with this challenging condition.
