Novartis has announced plans to significantly expand its clinical programme on the antihypertensive Rasilez/Tektura to 35,000 patients in 14 trials.
The Basel-based company said that the newly launched studies will evaluate the organ protection potential of the first-in-class direct renin inhibitor Rasilez (aliskiren) “beyond documented ability to provide powerful blood pressure reductions that last beyond 24 hours”.
The studies which make up the Aspire Higher clinical programme will include three mega-trials to explore Rasilez benefits in difficult-to-treat patients with “life-threatening co-morbidities” – heart failure, cardiovascular events in elderly and diabetic kidney disease. The Aspire project will be “the largest and most far-reaching cardio-renal outcomes programme worldwide”, Novartis said.
Trevor Mundel, head of global development functions at Novartis Pharma, said that data already reported from the programme have shown the potential for Rasilez to protect organs such as the heart and kidneys. “We look forward to the results of these additional long-term outcome studies that we hope will demonstrate the benefits of Rasilez independent of its powerful blood pressure reductions,” he added.
Novartis withdraws EU flu vaccine application
The Rasilez announcement came just after it was revealed that Novartis has withdrawn an marketing application for its Aflunov pandemic influenza vaccine in Europe.
The jab had been under review by the European Medicines Agency’s Committee for Medicinal Products for Human Use and the EMEA says it had been expected to be used for pre-pandemic immunisation against the H5N1 subtype of the influenza A virus. However, Novartis told the agency it could not supply additional data that had been requested by the CHMP within the required timeframe.
