Cal­lid­i­tas nabs ac­cel­er­at­ed OK for rare kid­ney dis­ease, beat­ing two com­peti­tors to the punch

Since its found­ing, Cal­lid­i­tas has wa­gered it could bring to mar­ket a new for­mu­la­tion of an oral steroid to treat a rare kid­ney dis­ease. And on Wednes­day af­ter­noon, its bet paid off.

The FDA grant­ed ac­cel­er­at­ed ap­proval to the biotech’s de­layed-re­lease budes­onide cap­sules, Cal­lid­i­tas an­nounced, wav­ing through a new treat­ment for the re­duc­tion of pro­tein­uria in pri­ma­ry IgA nephropa­thy. Wednes­day’s ap­proval came af­ter reg­u­la­tors de­layed the PDU­FA date by three months, as Cal­lid­i­tas said the agency re­quest­ed fur­ther analy­ses.

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