EU CHMP recommends lesinurad with a xanthine oxidase inhibitor (XOI) for the adjunctive treatment of hyperuricaemia in adult gout patients.- AstraZeneca

AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the marketing authorisation of lesinurad 200mg tablets. Lesinurad, in combination with a xanthine oxidase inhibitor (XOI), is recommended for the adjunctive treatment of hyperuricaemia in adult gout patients (with or without tophi) who have not achieved target serum uric acid levels (sUA) with an adequate dose of a XOI alone. The CHMP�s positive opinion on lesinurad will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).

Comment: Lesinurad is also under review in the United States. On 23 October 2015, the FDA�s Arthritis Advisory Committee recommended the approval of lesinurad 200mg tablets for the treatment of hyperuricemia associated with gout, in combination with an XOI. The Prescription Drug User Fee Act (PDUFA) target goal date is 29 December 2015.