Aliskiren (Novartis)availability terms agreed with FDA

Novartis announced that the Tekturna labels have been updated in the USA, following the FDA review of the preliminary findings from the ALTITUDE study.The label change includes a contraindication against combined use of aliskiren-based products with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) in patients with diabetes. The FDA has also requested the inclusion of a warning against the use of aliskiren-based products in patients with moderate renal (kidney) impairment (eGFR < 60 ml/min) who are also taking an ACE inhibitor or an ARB. Aliskiren-based products will continue to be available in the USA for the treatment of high blood pressure in appropriate patients. Furthermore, and in consultation with the FDA, Novartis has decided to voluntarily cease marketing in the US of Valturna (aliskiren and valsartan, USP), a single pill combination of aliskiren and the ARB valsartan. Valturna sales in the US represented less than 10% of Aliskiren sales in 2011. Novartis advises US patients to seek guidance from their prescribing healthcare provider at their next (non-urgent) visit to determine appropriate alternate therapy. Novartis has also decided to voluntarily withdraw marketing authorization of the same combination pill in Switzerland, Rasival (aliskiren and valsartan), which received marketing approval for export but was not launched. The US Prescribing Information has been updated for Tekturna, Tekturna HCT (aliskiren and hydrochlorothiazide), Tekamlo (aliskiren and amlodipine) and Amturnide (aliskiren, amlodipine and hydrochlorothiazide). In view of the importance of controlling high blood pressure and to enable physicians to transition patients to alternate therapies, Novartis will make Valturna available in the US until July 20, 2012.