The FINANCIAL -- Novartis
announced that the European Medicines Agency's Committee for
Medicinal Products for Human Use has concluded the risk-benefit
review of Rasilez and combination products containing aliskiren and
confirmed it remains positive in the European Union for the
treatment of essential hypertension.
According to Novartis AG, in addition, the CHMP has requested an update to the product information of Rasilez 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 inhibitor or angiotensin receptor blocker who also have diabetes and/or moderate to severe renal impairment. 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 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.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.
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