CHMP backs Ilaris for gouty arthritis

EMA's CHMP issued a number of positive opinions on Friday, including a recommendation to expand the label for Ilaris canakinumab from Novartis AG (NYSE:NVS; SIX:NOVN) to include treatment of gouty arthritis. Ilaris is recommended to treat adults with frequent gouty arthritis attacks in whom NSAIDs and colchicine are contraindicated, are not tolerated or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate. Canakinumab is approved in more than 60 countries, including those in the EU, to treat cryopyrin-associated periodic syndromes (CAPS). Novartis said it is "continuing to work with FDA" to determine next steps in the U.S. for canakinumab for gouty arthritis. In August 2011, FDA issued a complete response letter for the drug in the indication and asked for additional information, including clinical data.

CHMP also backed conditional approval of an MAA from Pfizer Inc. (NYSE:PFE) for Bosulif bosutinib to treat adults with chronic, accelerated or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) previously treated with at least one tyrosine kinase inhibitor and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options. The recommendation was based on data from the single-arm Phase I/II Study 200 trial in more than 500 patients. In September, FDA granted full approval for the dual inhibitor of BCR-ABL and Src kinase based on the Study 200 data. ...