Io­n­is, As­traZeneca go­ing to FDA with PhI­II da­ta in hand; Glaukos touts dou­ble PhI­II win in eye im­plant

Io­n­is and As­traZeneca are hop­ing its lat­est re­sults net an FDA ap­proval.

The two com­pa­nies pre­sent­ed their lat­est Phase III re­sults from a 35-week analy­sis of the Phase III tri­al, dubbed NEU­RO-TTRans­form, of As­traZeneca’s eplon­ter­sen in pa­tients with the rare dis­ease known as hered­i­tary transthyretin-me­di­at­ed amy­loid polyneu­ropa­thy (AT­TRv-PN).

Ac­cord­ing to Io­n­is on Wednes­day, Phase III had a pos­i­tive out­look as eplon­ter­sen achieved an 81.2% re­duc­tion of serum transthyretin (TTR) con­cen­tra­tion in pa­tients com­pared to base­line, demon­strat­ing re­duced TTR pro­tein pro­duc­tion. This hit the co-pri­ma­ry end­point of the tri­al and earned a p-val­ue of p=<0.0001.

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