FDA issues complete response letter to filing of canakinumab for cardiovascular risk.- Novartis.

The FDA has issued a complete response letter after ACZ 885 (canakinumab), from Novartis, was filed with the agency as a targeted therapy for those cardiovascular patients in who, tests showed, levels of a blood protein associated with inflammation and heart disease had dropped rapidly. This filing was based on data from CANTOS, a Phase III study evaluating quarterly injections of ACZ 885 in people with a prior heart attack and inflammatory.

The study met its primary endpoint, showing that ACZ 885 led to a statistically significant 15% reduction in the risk of major adverse cardiovascular events, a composite of non-fatal heart attack, non-fatal stroke and cardiovascular death, compared to placebo. This benefit was sustained throughout the duration of the study (median follow up 3.7 years) and was largely consistent across key pre-specified baseline sub groups.

Comment: Canakinumab can lower the risk of lung cancer as well as cardiovascular disease by reducing inflammation according to the data from the CANTOS study. Researchers say the findings are a validation of the inflammation hypothesis in atherosclerosis, ushering in a new era in cardiovascular disease prevention, and at the same time opening up new possibilities in cancer treatment.