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 AstraZeneca's 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). The final decision will be applicable to all 28 EU member countries plus Iceland, Norway and Liechtenstein. AstraZeneca anticipates a final decision by the EC in the first quarter of 2016. If approved, lesinurad will be the first selective uric acid reabsorption inhibitor (SURI) to treat patients with inadequately controlled gout in Europe.

SURI inhibits the urate transporter, URAT1, which is responsible for the majority of the renal reabsorption of uric acid. By inhibiting URAT1, lesinurad increases uric acid excretion and thereby lowers sUA.

Lesinurad is also under review in the United States. On October 23, 2015, the US Food and Drug Administration’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 December 29, 2015.

Gout is a serious and debilitating form of inflammatory arthritis caused by hyperuricemia (elevated sUA). It affects millions of patients, many of whom do not reach recommended sUA treatment goals on the current standard of care (XOIs), which decrease production of uric acid. For those inadequately controlled patients, the addition of a urate lowering therapy to increase excretion of uric acid, may help them achieve treatment goals.

The goal of sUA lowering treatment is to reduce sUA levels to the target level of <6.0mg/dL (360 µmol/L) as recommended by both the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR). In those with greater disease severity and urate burden, such as those with tophi, guidelines recommend lowering sUA to <5.0 mg/dL (300 µmol/L) to achieve better disease control.

Among patients treated in clinical trials, less than 50 per cent of patients on allopurinol 300mg reached sUA target levels <6.0mg/dL (360 µmol/L). For patients who cannot reach target on an XOI alone, the current ACR and EULAR guidelines recommend adding an agent that increases uric acid excretion. Major markets include the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.