Novartis has decided not to pursue its bid to get approval in Europe for the hypertensive combination containing the Swiss major’s Tekturna/Rasilez and Diovan due to the additional data regulators require.
The European Medicines Agency says it has been formally notified by Novartis of its decision to withdraw its application for a centralised marketing authorisation for the medicine, which would have been known as Rasival and is a single-pill combination of Tekturna (aliskiren) and Diovan (valsartan).
The combo was intended to be used for the treatment of essential hypertension in adults whose blood pressure is not adequately controlled with aliskiren and valsartan on their own. The application was submitted to the agency in May 2009.
At the time of the withdrawal, it was under review by the EMA’s Committee for Medicinal Products for Human Use (CHMP). Novartis stated that the decision is based on its "inability to address the CHMP’s requests and provide additional data within the timeframe allowed in the centralised procedure".
More information about the state of the scientific assessment at the time of withdrawal will be made available following the next CHMP meeting scheduled for September 20-23. The agency noted that Novartis can still make a new application at a later stage.
The combo was approved by the US Food and Drug Administration in September last year under the brand name Valturna.