Novartis withdraw marketing application for heart drug

pharmafile | December 17, 2018 | News story | Sales and Marketing CHMP, EMA, MI, Novartis, pharma 

Swiss multinational Novartis has withdrawn a European Medicines Agency (EMA) marketing application for canakinumab for the prevention of serious events such as stroke, myocardial infarction (MI) or death in patients who have had an MI.

The move comes after the EMA suggested that the CHMP held concerns over the application while complaining that the data Novartis had submitted was ‘not robust enough’ to show that canakinumab is effective in all patients who have had an MI. Furthermore the regulator claimed that the drug had only ‘modest’ benefits, particularly in patients who also took statins.

The EMA added that the benefits of the drug were not considered sufficient enough when weighed against the increased risks of serious infections in patients treated with the medicine. 

Novartis withdrew the application due to the fact that the company would not be able to address the EMA’s concerns within the agreed timeframe, the EMA said.

Canakinumab did however meet its primary endpoint in Phase III CANTOS trial last year illustrating that quarterly injections of canakinumab reduced the risk of major adverse cardiovascular events in certain patients who had a prior heart attack by 15 percent.

Louis Goss

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