Renée Aguiar-Lucander

Not so fast: FDA tacks 3 more months on­to de­ci­sion date for Cal­lid­i­tas' rare kid­ney dis­or­der drug

It looks like the FDA’s de­ci­sion on Cal­lid­i­tas’ IgA nephropa­thy can­di­date Ne­fe­con is go­ing to take a few months longer than ex­pect­ed — al­low­ing time for ri­vals like Mar­tin Shkre­li’s for­mer com­pa­ny Tra­vere Ther­a­peu­tics to catch up.

Five months af­ter grant­i­ng Ne­fe­con pri­or­i­ty re­view, the FDA is ex­tend­ing its PDU­FA date from Sept. 15 to Dec. 15, Cal­lid­i­tas an­nounced on Tues­day. The Swiss biotech filed for ac­cel­er­at­ed ap­proval back in March, based on da­ta from 200 pa­tients in the first part of the Phase III Ne­fI­gArd tri­al who showed a sig­nif­i­cant re­duc­tion in pro­tein­uria, or ex­ces­sive pro­tein in the urine.

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