LONDON (Reuters) - Swiss drugmaker Novartis has withdrawn a marketing application for its drug Ruvise, designed to treat arterial hypertension, the European Medicines Agency (EMA) said on Thursday.
The drug, known generically imatinib mesilate, was intended for use in adults as add-on therapy for the treatment of pulmonary arterial hypertension (PAH), the drug regulator said in a statement.
EMA reported that Novartis had said that the withdrawal was because it requires additional data to address the regulator’s questions relating to its benefit-risk assessment.
The data would not be available within the timeframe allowed in the centralized procedure, it said.
Reporting by Kate Kelland; Editing by David Goodman