FDA ap­proves GSK's ane­mia drug with safe­ty warn­ing — af­ter bat­ting back sim­i­lar drugs

GSK has se­cured the first of four US ap­provals it’s hop­ing for this year, as the FDA green­lit dapro­du­s­tat as a treat­ment for ane­mia due to chron­ic kid­ney dis­ease.

But the FDA lim­it­ed the use of the drug, to be mar­ket­ed as Jes­du­vroq, to pa­tients who have been re­ceiv­ing dial­y­sis for at least four months and stopped short of ap­prov­ing it for pa­tients not de­pen­dent on dial­y­sis — in line with the rec­om­men­da­tions of the ad­vi­so­ry com­mit­tee it con­sult­ed.

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