FDA Advisory Panel endorses Approval of Lesinurad for Gout Patients

AstraZeneca, multinational pharmaceutical and Biologics Company, announced today that the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee (AAC) voted 10-4 to put forward for consent of lesinurad 200 mg tablets, which are used in the treatment of hyperuricemia linked with gout, in amalgamation with a xanthenes oxidase inhibitor (XOI).

The AAC assessed desired results from the crucial Phase-III amalgamation therapy program trials, which was the largest clinical data set of gout patients treated along with urate-lowering therapy.

All 10 supporters of the drug, lesinurad, passed their voting by compelling the FDA to ask AstraZeneca for studies after lesinurad launch to measure its long-lasting effectiveness and safety.

Gout is a type of arthritis in which more of uric acid forms crystals in joints that cause tender inflammation.

If approved, it will be for the first time in 60 years that the drug will be used to tackle inefficient excretion in gout patients, said AstraZeneca.

The panel’s advice follows an FDA staff review that raised questions about lesinurad benefit-risk profile, majorly linked to increased renal and cardiovascular risks.

Mostly members agreed in the FDA panel about lesinurad’s benefit. The members not in favor of the drug said its safety profile prohibited their support.

The drug is made in amalgamation with an older drug named febuxostat that works by diminishing the production of uric acid and raising its excretion. Currently used drug is an oral one called allopurinol.