On Friday, the FDA approved BridgeBio Pharma, Inc.'s (NASDAQ:BBIO) 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, which showed that Attruby significantly reduced death and cardiovascular-related hospitalization and improved quality of life.
Also Read: BridgeBio Pharma's Acoramidis Shows Competitive Edge Against Pfizer's Tafamidisa In Lucrative But Competitive ATTR-CM Market
Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR.
Attruby was designed to mimic a naturally occurring "rescue mutation" of the TTR gene (T119M) that targets the root cause of ATTR-CM, the destabilization of the native TTR tetramer.
Through near-complete TTR stabilization, 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.
The ATTRibute-CM Phase 3 study enrolled 632 participants with symptomatic ATTR-CM associated with either wild-type or variant TTR.
BridgeBio submitted a Marketing Authorization Application to the European Medicines Agency, with a decision expected in 2025.
BridgeBio has granted Bayer AG (OTC:BAYRY) exclusive rights to commercialize acoramidis for ATTR-CM in Europe.
The company said it will provide Attruby for free to patients who participated in the trial.
William Blair writes, "We continue to view a reduction in all-cause mortality on label as a necessary distinction to gain major market share in ATTR-CM alongside Pfizer Inc's (NYSE:PFE) tafamidis."
Since the Attruby label doesn't include data on overall mortality, the William Blair analyst notes Pfizer might shift its marketing focus to emphasize claims about mortality benefits.
Price Action: BBIO stock is up 24.3% at $29.10 during the premarket session at last check Monday.
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