Novartis to revise product information in the European Union for high blood pressure drug Rasilez following assessment by CHMP

CHMP concluded the risk-benefit review of Rasilez* (aliskiren) and confirmed it remains positive for the treatment of essential hypertension

CHMP has requested that the Rasilez (aliskiren) product information be updated in the EU to include a contraindication against combined use of aliskiren with an ACE inhibitor or an ARB in patients with diabetes and/or patients with moderate to severe renal impairment

CHMP has also requested the inclusion of a warning against the use of aliskiren in patients who are taking an ACE inhibitor or an ARB

This decision follows extensive interactions between Novartis and the CHMP following the Novartis decision in December 2011 to halt the ALTITUDE study after unexpected preliminary findings

Patient safety is the highest priority for Novartis, and we will continue to work with health authorities worldwide in the best interest of patients

Basel, February 17, 2012 - Novartis announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has concluded the risk-benefit review of Rasilez and combination products containing aliskiren and confirmed it remains positive in the European Union (EU) 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.

"This decision comes after extensive interactions between Novartis and the CHMP. Patient safety continues to be the highest priority for Novartis, and we are working closely with the CHMP, EMA and other health authorities worldwide to continue to provide Rasilez and combination products containing aliskiren to the most appropriate patient population who would benefit," said David Epstein, Division Head of Novartis Pharmaceuticals.

The product information for Rasilez and combination products containing aliskiren in the EU are being updated. Novartis will also write to physicians in the EU informing them of these changes to the product information.

The CHMP review of Rasilez risk-benefit began in December 2011 following the Novartis decision to halt the ALTITUDE study after the Data Monitoring Committee reviewed preliminary interim analyses and concluded that study patients were unlikely to benefit from aliskiren and there was a higher incidence of adverse events related to non-fatal stroke, renal complications, hyperkalaemia and hypotension in this high-risk population.

Starting in December 2011, 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 US FDA. As a precautionary measure, in December 2011 Novartis stopped promotion of Rasilez/Tekturna and combination products containing aliskiren in combination with an ACE inhibitor or ARB.

Based on the revised product information, physicians in the EU will now be advised that patients who have diabetes and/or moderate to severe renal impairment, who are also taking Rasilez and an ACE inhibitor or an ARB, should receive alternate treatment under a physician’s supervision. In other patients taking Rasilez or combination products containing aliskiren in combination with an ACE inhibitor or an ARB, the balance of benefits and risks of continuing treatment should be considered carefully.

Any patients using Rasilez or combination products containing aliskiren who may have questions about their medication should consult their healthcare provider. visit http://www.novartis.com/newsroom/rasilez-tekturna-information-center/index.shtml.

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 .

About Aliskiren
Aliskiren was approved in the EU and US in 2007 under the brand names Rasilez and Tekturna respectively, for the treatment of hypertension either as monotherapy or in combination with other medications. It is available in 63 countries. These products remain available for appropriate patients.

Rasilez-based products available in the EU include:

Rasilez/ Sprimeo/ Riprazo

Rasilez HCT/ Sprimeo HCT/ Riprazo HCT, a single-pill combination of Rasilez and hydrochlorothiazide (HCT)

Rasilamlo, a single-pill combination of Rasilez and amlodipine

Rasitrio, a triple combination of Rasilez, amlodipine and hydrochlorothiazide (HCT)

About ALTITUDE
ALTITUDE was a multinational study in 8,606 patients from 36 countries evaluating the potential benefits of aliskiren to reduce the risk of cardiovascular and renal events in this patient population.

ALTITUDE was the first randomized, double-blind, placebo-controlled study to investigate aliskiren for more than one year in a specific population of patients with type 2 diabetes and renal impairment. These patients are known to be at high risk of cardiovascular and renal events. In the study, aliskiren was given in addition to optimal cardiovascular treatment including an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).