CHMP defines limits of aliskiren (Novartis) in Hypertension

Novartis announced that the CHMP has concluded the risk-benefit review of Rasilez (aliskiren) and combination products containing aliskiren and confirmed it remains positive in the European Union for the treatment of essential Hypertension. In addition, the CHMP has requested an update to the product information of Rasilez� (aliskiren) and combination products containing aliskiren available in the EU. The CHMP has requested that Rasilez and combination products containing aliskiren are contraindicated in patients who are receiving an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) who also have diabetes and/or moderate to severe renal impairment (GFR < 60 ml/min/1.73 m2). In addition, the CHMP has requested the inclusion of a warning against the use of Rasilez and combination products containing aliskiren in patients who are also taking an ACE inhibitor or an ARB. Novartis wrote to physicians worldwide recommending that patients with Type 2 Diabetes should not be treated with aliskiren, or combination products containing aliskiren, if they are also receiving an ACE inhibitor or ARB. This recommendation remains in place in countries outside of the EU as Novartis continues discussions with the respective health authorities, including the FDA. The CHMP has requested that Rasilez and combination products containing aliskiren are contraindicated in patients who are receiving an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) who also have diabetes and/or moderate to severe renal impairment (GFR < 60 ml/min/1.73 m2). In addition, the CHMP has requested the inclusion of a warning against the use of Rasilez and combination products containing aliskiren in patients who are also taking an ACE inhibitor or an ARB.The label changes in the EU will be applied to all approved aliskiren-based products. These products include Rasilez�, Sprimeo�, Riprazo�, Rasilez HCT�, Sprimeo HCT�, Riprazo HCT�, Rasilamlo�, and Rasitrio�.