CHMP recommends approval of Duzallo for hyperuricaemia in gout.- Gruenenthal.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Duzallo (lesinurad + allopurinol), from Gruenenthal, intended for the treatment of hyperuricaemia in gout patients. Duzallo is a fixed dose combination of two active substances, lesinurad and allopurinol. It will be available as film -coated tablets (300 mg /200 mg and 200 mg/200 mg). Lesinurad is a selective uric acid reabsorption inhibitor that inhibits uric acid transporter 1, and allopurinol reduces uric acid production by inhibition of xanthine oxidase (ATC code: M04AA51).

The benefit of Duzallo is its ability to lower the level of uric acid in plasma and urine through increased uric acid excret ion and decreased uric acid production. The most common side effects are influenza, gastro-oesophageal reflux disease, headache and increased blood creatinine. The full indication is: “Duzallo is indicated in adults for the treatment of hyperuricaemia in gout patients who have not achieved target serum uric acid levels with an adequate dose of allopurinol alone.”

Comment: Duzallo is the first drug that combines the current standard of care for the treatment of hyperuricemia associated with gout, allopurinol, with the most recent FDA-approved treatment for this condition, lesinurad. This fixed-dose combination provides a dual mechanism of action in a single tablet that can address both underlying causes of hyperuricemia – overproduction and underexcretion of serum uric acid..