FDA Ad Comm backs AstraZeneca's lesinurad for gout-associated hyperuricemia

The regulator's advisory committee recommendation on AstraZeneca plc (ADR) (NYSE:AZN)'s Lesinurad 200 mg tablets is not binding on them.

The US FDA's Arthritis Advisory Committee voted in favour by a count of 10 to 4. According to the Prescription Drug User Fee Act, the target date for Lesinurad is December 29 current year.

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

The committee was unanimous on the question of whether a combination of AstraZeneca's drug and generic first-line treatment can make a difference in gout symptoms, but the panel split 7-6 with one abstention when asked whether the drug's safety profile merited approval.

A majority of voting FDA panel members agreed lesinurad's benefit was modest, but meaningful.

The AAC elected to favor the drug after assessing its safety and efficiency info throughout the crucial Phase III combination therapy trials.

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.

AZ acquired lesinurad as part of its $1.3bn takeover of Ardea Biosciences in 2012, an acquisition which also included a second gout candidate (RDEA3170) that is in mid-stage clinical testing.

The current standard of care for gout is an oral drug called allopurinol, which is known to have rare but potentially fatal adverse effects involving skin.

As of 09:40 GMT, AstraZeneca's share price had added 0.32 percent to stand at 4,082.50p, as compared with a 0.17-percent fall in the benchmark FTSE 100 index.