Novartis withdraws from EMA its application for canakinumab for the prevention of serious CV events.

The European Medicines Agency states that Novartis withdrew a marketing application seeking approval of canakinumab for the prevention of serious events such as stroke, myocardial infarction (MI) or death in patients who have had an MI. The news comes shortly after Novartis indicated that the FDA issued a complete response letter to a filing seeking approval of the drug, also known as ACZ 885, for cardiovascular risk reduction.

According to the EMA, at the time of the withdrawal, its Committee for Medicinal Products for Human Use (CHMP) had "concerns" over the application, and was minded to issue a negative opinion on the filing. The regulator explained that data submitted by Novartis was "not robust enough" to show that canakinumab is effective in all patients who have had an MI, while there were only "modest" benefits, particularly in patients who also took statins. The EMA further noted that the benefits of the drug were not considered enough to outweigh the increased risks of serious infections in patients treated with the medicine.

According to the EMA, Novartis withdrew the application, as it said it would not be possible to address the concerns within the agreed timeframe. Meanwhile, the EMA indicated that studies of canakinumab for the treatment of other conditions will be unaffected by this decision.