Al­ny­lam's po­ten­tial fourth RNAi ap­proval de­layed three months, but im­pact like­ly to be 'mod­est'

Al­ny­lam, look­ing to best its own AT­TR drug On­pat­tro, will have to wait up to three months longer than orig­i­nal­ly slat­ed for an FDA de­ci­sion on its in­ves­ti­ga­tion­al med vutrisir­an.

The agency plans to de­cide the fate of Al­ny­lam’s fourth RNAi ther­a­peu­tic on Ju­ly 14. The FDA doesn’t want any more clin­i­cal da­ta, but new­ly added in­for­ma­tion re­lat­ed to the “new sec­ondary pack­ag­ing and la­bel­ing fa­cil­i­ty” needs to be re­viewed, Al­ny­lam said Mon­day morn­ing.

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