Complete response for canakinumab

FDA issued a complete for response letter for gouty arthritis candidate canakinumab from Novartis AG (NYSE:NVS; SIX:NOVN). According to the pharma, FDA asked for additional information, including clinical data, to evaluate the benefit-risk profile in refractory patients. Novartis, which is working with FDA to determine next steps, said it is premature to speculate on when it would submit a response to the letter.

In June, an FDA advisory committee voted 11-1 against approval of canakinumab for gouty arthritis in patients who cannot obtain adequate responses with NSAIDs or colchicine (see BioCentury, June 27). ...