17 December 2018 - Novartis has pulled back its application to market canakinumab for the prevention of serious events such as stroke, myocardial infarction or death in patients who have had a myocardial infarction in Europe.

The move comes just weeks after an application to expand the drug’s approved uses in the US to include cardiovascular risk reduction was rejected by the US FDA.

The company is yet to provide any details on why canakinumab – an anti-inflammatory marketed under the brand name Ilaris for a variety of conditions, including Stills disease and gouty arthritis – was rejected in the US, but the development, together with withdrawal of the EU filing, cast a shadow of doubt over the drug’s future in the cardiovascular setting.

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