Tra­vere Ther­a­peu­tics just miss­es on con­fir­ma­to­ry study for kid­ney dis­ease drug, stock plum­mets

Tra­vere Ther­a­peu­tics’ kid­ney dis­ease drug nar­row­ly failed its con­fir­ma­to­ry study sev­en months af­ter it won ac­cel­er­at­ed ap­proval.

Tra­vere said Thurs­day it still in­tends to ap­ply for full ap­proval of Filspari in IgA nephropa­thy in the first half of next year, mean­ing the FDA will have to weigh the study re­sults and de­cide whether to pull the drug.

The key end­point in the Phase III study was a mea­sure of kid­ney func­tion known as es­ti­mat­ed glomeru­lar fil­tra­tion rate (eGFR) to­tal slope. The small­er the slope, the slow­er the de­cline of kid­ney func­tion. Pa­tients ei­ther re­ceived Filspari or irbe­sar­tan — a gener­ic blood pres­sure drug used to treat nephropa­thy. Over 110 weeks, pa­tients who re­ceived Filspari saw a small­er change in their eGFR to­tal slope com­pared to those in the com­para­tor arm. But the dif­fer­ence be­tween the to­tal slopes of the two groups had a p-val­ue of 0.058, just miss­ing sta­tis­ti­cal sig­nif­i­cance.

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