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Reported Friday, BridgeBio's Attruby Earns FDA Nod As First Therapy With ≥90% TTR Stabilization, Offering Hope For ATTR-CM Patients

金曜日に報告された、BridgeBioのアトルビーがFDAから承認を受け、TTR安定化率が90%以上の最初の治療法として、ATTR-Cm患者に希望をもたらします。

Benzinga ·  2024/11/24 23:31
  • Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR. Attruby has been shown to preserve the native function of TTR as a transport protein of thyroxine and vitamin A and to demonstrate benefit on cardiovascular outcomes
  • Attruby demonstrated the most rapid benefit seen in any Phase 3 study of ATTR-CM to date:
  • In as few as 3 months, the time to first event (all-cause mortality (ACM) or cardiovascular-related hospitalizations (CVH)) durably separated relative to placebo
  • A 42% reduction in composite ACM and recurrent CVH events relative to placebo at Month 30
  • A 50% reduction in the cumulative frequency of CVH events relative to placebo at Month 30
  • To honor the courage of our U.S. clinical trial participants, BridgeBio will provide these patients Attruby free for life
  • To learn about our extensive suite of programs to provide access to Attruby call 1-888-55-BRIDGE (1-888-552-7434)
  • With this approval, BridgeBio will receive a $500 million payment under our royalty funding agreement
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