BridgeBio eyes US filing for ATTR-CM drug after new PhIII data show ‘fastest’ clinical benefit to date

Bridge­Bio is prepar­ing to sub­mit an FDA fil­ing for its transthyretin amy­loid car­diomy­opa­thy (AT­TR-CM) drug can­di­date, dubbed aco­ramidis, be­fore the end of the year af­ter up­dat­ed reg­is­tra­tional da­ta in­di­cat­ed the treat­ment re­duced time to clin­i­cal ben­e­fit three­fold.

The Phase III AT­TRibute-CM tri­al stud­ied aco­ramidis ver­sus place­bo in 632 peo­ple with symp­to­matic AT­TR-CM. Topline da­ta pub­lished in Ju­ly showed the drug, at 30 months, met the tri­al’s com­pos­ite pri­ma­ry end­point, which mea­sured all-cause mor­tal­i­ty and car­dio­vas­cu­lar-re­lat­ed hos­pi­tal­iza­tion rates as well as changes from base­line in NT-proB­NP lev­els and the six-minute walk test (p<0.0001).

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