Novartis has withdrawn a marketing application to get approval in Europe for its cancer blockbuster imatinib, sold as Glivec/Gleevec, as a treatment for pulmonary arterial hypertension.
The European Medicines Agency has been formally notified by the Swiss major of its decision to pull the submission for the medicine, which would have been marketed as Ruvise, as add-on therapy for the treatment of PAH. The file has been under review by the agency’s Committee for Medicinal Products for Human Use since the end of last February.
However, Novartis is not taking the application any further "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, the company notes, hence the withdrawal.
The EMA says it will provide more information about Ruvise and the state of the scientific assessment at the time of withdrawal after the next CHMP meeting, scheduled for February 18-21. Glivec, which is approved for chronic myeloid leukaemia and gastrointestinal stromal tumours, is currently Novartis' best-selling product; fourth-quarter sales reached $1.18 billion but that represented a 5% fall on the like, year-earlier period.