Agency says it can’t approve canakinumab without further evaluation of benefit/risk profile in refractory patients.
FDA has gone along with the recommendations of its scientific advisory committee and refused to approve Novartis’ monoclonal antibody canakinumab (ACZ885) for the treatment of gouty arthritis. The complete response letter issued to the firm has requested additional clinical data to evaluate the benefit/risk profile in refractory patients.
The agency’s CRL reflects the opinion of the scientific advisory committee, which in June said that while it was happy with the overall efficacy of canakinumab, it did have some safety concerns, and suggested that retreatment data would be needed in order to assess the overall safety profile of the drug.
Novartis reported positive data from two Phase III studies evaluating the drug in the treatment of severe gouty arthritis back in May. Regulatory submissions were made in the EU in 2010, and in the U.S., Canada, and Switzerland in the first quarter of 2011.
Canakinumab is an IL-1β-targeting antibody that was approved in 2009 in Europe and the U.S., under the tradename Ilaris™, for the treatment of adults and children with cryopyrin-associated periodic syndrome (CAPS). The drug is now approved in over 45 countries for the CAPS indication, and achieved sales of $12 million in the second quarter of 2011, up 95% (in constant currency) on Q2 2010 sales.