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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