Novartis withdraws application at EMA for Ruvise treatment for PAH
The European Medicines Agency has been formally notified by Novartis Europharm Ltd of its decision to withdraw its application for a centralised marketing authorisation for the medicine Ruvise (imatinib mesilate), 100- and 400-mg film-coated tablets. It was intended to be used for adults as add-on therapy for the treatment of Pulmonary Arterial Hypertension.
The company stated that it is withdrawing the application since additional data are required to address CHMP questions relating to the benefit-risk assessment of imatinib in PAH patients. These data will not be available within the timeframe allowed in the centralised procedure.
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