FDA issues complete response for Arcalyst

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said FDA issued a complete response letter for an sBLA for Arcalyst rilonacept to prevent gout flares in patients initiating uric acid-lowering therapy. According to the company, FDA requested additional clinical data as well as CMC data related to a proposed new dosage form. Regeneron, which did not disclose details about the letter, said it is determining the next steps.

In May, FDA's Arthritis Advisory Committee voted 11-0 that efficacy and safety data do not support approval of Arcalyst. In briefing documents, agency reviewers expressed concern about an increased risk of malignancy and lack of long-term safety data for the product (see BioCentury Extra, May 8). ...