FDA panel backs<span class="*Red-type+bold"> AZ's gout therapy

FDA's Arthritis Advisory Committee voted 10-4 to recommend approval of 200 mg once-daily lesinurad ( RDEA594) from AstraZeneca plc (LSE:AZN; NYSE:AZN) in combination with a xanthine oxidase inhibitor to treat hyperuricemia associated with gout. The committee voted 14-0 that lesinurad demonstrated a clinically meaningful benefit, but was split on the question of safety. Panelists voted 7-6, with one abstention, that the therapy's safety profile adequately supported approval.

In briefing documents released ahead of Friday's meeting, FDA reviewers described an increase in renal and cardiovascular adverse events associated with a 400 mg dose of lesinurad compared with placebo across several studies. The 200 mg dose was associated with a smaller increased risk of AEs vs. the 400 mg dose, and only the 200 mg dose was considered for approval. ...