AstraZeneca's gout drug recommended by FDA committee

The US Food and Drug Administration's Arthritis Advisory Committee has recommended the approval of AstraZeneca's lesinurad tablets for the treatment of hyperuricemia associated with gout.

The FTSE 100 drug company announced the decision on Monday.

The committee recommended the drug to be used in combination with a xanthine oxidase inhibitor after it reviewed the phase three combination therapy programme trials.

If approved by the FDA, lesinurad will be the first selective uric acid reabsorption inhibitor in the US.

AstraZeneca chief medical officer Sean Bohen said the positive recommendation is an encouraging step for patients suffering from the debilitating effects of gout.

“We look forward to the outcome of the FDA's review and the opportunity to provide a new treatment option that, when combined with a xanthine oxidase inhibitor, addresses both the under-excretion and over-production of uric acid, the underlying causes of gout."

The target date under the Prescription Drug User Fee Act is 29 December 2015, and the drug is also under regulatory review in the European Union and other territories.