EMA fi­nal­izes clin­i­cal de­vel­op­ment guide­line for new gout treat­ments

The EMA on Thurs­day is­sued a guide­line set­ting its ex­pec­ta­tions for the clin­i­cal de­vel­op­ment of new urate-low­er­ing ther­a­pies (ULT) and an­ti-in­flam­ma­to­ry drugs to treat gout.

The 14-page guide­line comes less than a year af­ter the EMA’s Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use (CHMP) re­leased the draft ver­sion for con­sul­ta­tion and sev­en years af­ter the agency pub­lished a con­cept pa­per high­light­ing the need for such guid­ance.

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