February 18, 2011 - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Rasilamlo(TM) (aliskiren and amlodipine) to treat high blood pressure patients not adequately controlled by either aliskiren or amlodipine alone. Rasilamlo combines in a single pill the only approved direct renin inhibitor worldwide, Rasilez®, with the widely used calcium channel blocker amlodipine.The CHMP recommendation forms the basis for a European Commission licensing decision, which is expected in approximately three months.
"We are delighted with the CHMP opinion because it means that Rasilamlo could soon be made available to patients in the EU in need of effective combination treatments to help control their high blood pressure," said David Epstein, Division Head of Novartis Pharmaceuticals. "Novartis understands the complex needs of high blood pressure patients and is committed to furthering cardiovascular research and to developing innovative and effective treatments."... Novartis' Press Release -
