BridgeBio’s Attruby wins FDA approval

The US Food and Drug Administration (FDA) on Friday approved Attruby (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for the treatment of adults with ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalization.

The FDA approval is based on positive results seen in the ATTRibute-CM Phase III study, where Attruby significantly reduced death and cardiovascular-related hospitalization, and improved quality of life, said the drug’s developer, US genetic diseases and cancer drug company BridgeBio Pharma (Nasdaq: BBIO). Trading in the firm’s shares was halted on Friday ahead of the decision, which came well after markets closed.

“We are excited to be part of the celebration for the FDA approval of Attruby. The need for more treatment options for patients living with ATTR-CM is crucial to achieving the goal of better outcomes and improved quality of life. Access to this new therapy means more hope and more opportunity to improve the lives of patients with amyloidosis,” said Muriel Finkel, president of Amyloidosis Support Groups, a non-profit organization dedicated to the support of amyloidosis patients and caregivers.