FDA rais­es safe­ty ques­tions with GSK's po­ten­tial CKD drug ahead of ad­comm

The FDA’s Car­dio­vas­cu­lar and Re­nal Drugs Ad­vi­so­ry Com­mit­tee to­mor­row will vote on whether the ben­e­fits of GSK’s dapro­du­s­tat, an oral hy­pox­ia-in­ducible fac­tor-pro­lyl hy­drox­y­lase in­hibitor, out­weighs its risks for the treat­ment of ane­mia due to chron­ic kid­ney dis­ease (CKD) in adult pa­tients not on dial­y­sis and on dial­y­sis.

Once laud­ed as a top drug in the British drug­mak­er’s late-stage pipeline by for­mer R&D chief Hal Bar­ron, the FDA is now rais­ing some se­ri­ous ques­tions about the ben­e­fits giv­en some of the po­ten­tial risks, not­ing that it’s “seek­ing the ad­vi­so­ry com­mit­tee’s ad­vice and rec­om­men­da­tions on these safe­ty is­sues,” adding:

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