BridgeBio and Alnylam's Entrants Rival Pfizer's Tafamidis in ATTR-CM Treatment Landscape

The FDA's acceptance of new drugs for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) marks an important development in this competitive field. Following BridgeBio's approval for Attruby, a potent new TTR stabilizer, the FDA has now agreed to review Alnylam’s Amvuttra (vutrisiran), which stands out as an RNA interference therapeutic aimed at reducing mutant and wild-type TTR levels, addressing the root cause of ATTR-CM rather than merely stabilizing the TTR tetramer like existing treatments such as Pfizer's tafamidis and BridgeBio's Attruby[1]. Amvuttra's potential approval could introduce the first RNAi treatment option for ATTR-CM, backed by promising Phase III HELIOS-B trial results that demonstrated a significant reduction in mortality and recurrent cardiovascular events, setting it apart as a strong contender in the evolving therapeutic landscape[1]. As the FDA sets a PDUFA date for March 23, 2025, for Amvuttra, no advisory committee meeting is planned, indicating a streamlined review process amidst an increasingly competitive market[1].