EMEA clears Rasilez for high blood pressure

Swiss drug major Novartis says it has received European Medicines Agency (EMEA) approval for its antihypertensive Rasilez (aliskiren). The drug has been cleared as a therapy for high blood pressure either alone or in combination with other medications in all 27 European Union member states, plus Norway and Iceland.

Rasilez, which inhibits the enzyme renin, has already been approved in the USA, where it is sold under the brand name Tekturna (Marketletter March 12). The drug was originally developed by Novartis in collaboration with fellow Swiss firm Speedel. The EMEA considered data from more than 7,800 patients in 44 clinical trials, which showed that the agent brought about greater blood pressure reductions than commonly-used medications, including angiotensin converting enzyme inhibitiors and diuretic hydrochlorothiazides.

The agency also received a positive approval recommendation from its Committee for Medicinal Products for Human Use (CHMP) earlier this year (Marketletter July 2).