News briefs: Novartis drops Ruvise MAA; B-MS settlement; Germany donates to Global Fund

25 January 2013

The European Medicines Agency says it has been formally notified by Swiss drug major Novartis (NOVN: VX) of its decision to withdraw its application for a centralized marketing authorization for the Ruvise (imatinib mesylate, the active ingredient of its cancer drug Glivec/Gleevec), 100mg and 400mg film-coated tablets. It was intended to be used for adults as add-on therapy for the treatment of pulmonary arterial hypertension (PAH).

In its official letter, the company stated that it is withdrawing the application since additional data are required to address by the Agency’s Committee for Medicinal Products for Human Use (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.

Bristol-Myers agrees $80 million settlement of hep C drug

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