Novartis has pulled back its application to market canakinumab for the prevention of serious events such as stroke, myocardial infarction (MI) or death in patients who have had an MI 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 Food and Drug Administration.
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.
The EMA said Novartis pulled its application after the CHMP had evaluated the documentation it provided and formulated lists of questions, which left unresolved issues.
The CHMP was of the provisional opinion that canakinumab could not have been approved for the prevention of serious heart problems in patients who have already had a heart attack, the regulator said.
In particular, the Committee was of the opinion that the data provided by the company was not robust enough to clearly demonstrate that canakinumab Novartis is effective in all patients who have had a heart attack.
“The beneficial effects seen were considered modest, particularly in patients who also took statins, and were not considered to outweigh the increased risks of serious infections in patients treated with the medicine.”
In its withdrawal letter to the Agency, Novartis stated that it would not be possible to reply to the Committee’s concerns within the agreed timeframe.
