Cal­lid­i­tas plans to file for full ap­proval for rare kid­ney dis­ease drug fol­low­ing PhI­II da­ta

Cal­lid­i­tas be­lieves Phase III con­fir­ma­to­ry da­ta it re­leased Sun­day for its oral steroid to treat a rare kid­ney dis­ease could be the fi­nal piece need­ed to get full ap­proval from the FDA.

The tri­al stud­ied Ne­fe­con, the biotech’s de­layed-re­lease budes­onide cap­sules mar­ket­ed as Tarpeyo, on pri­ma­ry IgA nephropa­thy (IgAN) pa­tients who were al­so on a RAS in­hibitor ther­a­py. Tarpeyo scored ac­cel­er­at­ed ap­proval from the agency in De­cem­ber 2021 and con­di­tion­al mar­ket­ing au­tho­riza­tion from the Eu­ro­pean Com­mis­sion in Ju­ly 2022.

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