Novartis pulls European marketing authorization application for aliskiren and valsartan combo Rasival; presents new data on Onbrez Breezhaler

The European Medicines Agency (EMEA) has been formally notified by Swiss drug major Novartis (NOVN. VX) of its decision to withdraw its application for a centralized marketing authorization for Rasival, a combination of aliskiren (a direct renin inhibitor sold as Rasilez in Europe and Tekturna in the USA) and valsartan (the active ingredient of its blockbuster antihypertensive Diovan which loses patent protection in 2012 but generated sales of $1.55 billion in second-quarter 2010), 150/160mg and 300/320mg film-coated tablets.

This combination drug was intended to be used for the treatment of essential hypertension as a substitution therapy in adults whose blood pressure is adequately controlled with aliskiren and valsartan, given as single components concurrently, at the same dose level as in the combination.

The application for Rasival’s approval was submitted to the Agency in May 2009. At the time of the withdrawal it was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP).