AZ’s gout drug gets FDA committee backing

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.

AstraZeneca Plc said a U.S. Food and Drug Administration advisory panel recommended approval of Lesinurad, a gout drug gained with the acquisition of Ardea Biosciences Inc. three years ago.

A majority of independent FDA advisers recommended approval for AstraZeneca’s ($AZN) new gout drug, but not without noting that the treatment’s safety profile presents considerable concerns going forward.

Gout is a form of arthritis in which excess uric acid forms crystals in joints and other tissues, causing painful inflammation.

The FDA doesn’t have to follow the advice of its advisory panels, though it often does.

The recommendation of the panel follows a staff review by the FDA last week, which raised questions over the benefit-risk of the drug, specifically related to increased renal and cardiovascular risks.

Lesinurad is used in conjunction with an older gout drug called febuxostat in order to lower the production of uric acid and boost its excretion, reports Reuters.

Ardea on Friday said that the medication was not made to be a first line treatment for the disorder, but the benefit risk of the drug profile was sufficiently positive for its approval as a therapy add-on.

Many patients do not reach target uric acid levels despite using current treatments, creating the need for effective additional therapies such as lesinurad, Ardea said.

AstraZeneca’s shares were up just under 1 percent at $31.36 in late afternoon trading.