FDA Panel Votes Against Approving Regeneron's Gout Drug

Law360, New York (May 8, 2012, 5:33 PM EDT) -- A U.S. Food and Drug Administration advisory panel voted unanimously against recommending approval of Regeneron Pharmaceuticals Inc.'s drug Arcalyst for gout flares Tuesday, with committee members saying they'd want to see longer-term studies of the drug on larger groups of patients.

The FDA's Arthritis Advisory Committee voted 11-0 that the existing efficacy and safety data don't support approving the drug, also known as rilonacept, for use over a 16-week period in preventing painful gout flares in patients initiating uric acid-lowering therapy to treat the condition, a...
To view the full article, register now.

UK Financial Services

UK Financial Services

Read Our Latest UK Financial Services Coverage

Financial Services Law360 UK provides breaking news and analysis on the financial sector. Coverage includes UK and European Union policy, enforcement, and litigation involving banks, asset management firms, and other financial services organizations.