Novartis will revise the product information for its hypertension drug Rasilez (aliskiren) to take account of new European Medicines Agency (EMA) drug interaction warnings.
A risk-benefit review from the EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded that aliskiren-containing medicines may interact harmfully with ACE inhibitors or ARBs.
The CHMP review followed Novartis’ decision in December 2011 to abandon the ALTITUDE trial of Rasilez used in combination with those medications.
While confirming that Rasilez is suitable for the treatment of essential hypertension (where no external risk factors present), the CHMP requested two changes in the product information in the EU:
• A contraindication against its use with an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) in patients with diabetes and/or moderate to severe renal impairment.
• A warning against its use in any patients who are taking an ACE inhibitor or an ARB, asking the doctor to assess the balance of risk and benefit carefully.
Novartis will inform doctors in the EU of these changes, which will also affect combination products containing aliskiren such as Rasilamlo and Rasitrio.
David Epstein, Division Head of Novartis Pharmaceuticals, commented: “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.”
The ALTITUDE study was a large-scale trial of Rasilez used in combination with an ACE inhibitor or ARB in a specific population of patients with type 2 diabetes and renal impairment to reduce the risk of cardiovascular and renal events.
Novartis halted the trial in December after the Data Monitoring Committee concluded from preliminary interim data that the combination in these patients not only did not reduce the risk of such events, but actually increased it.
The company warned doctors worldwide not to prescribe aliskiren-containing products to patients with diabetes who were receiving an ACE inhibitor or ARB. This warning remains in place outside the EU pending further discussions.
Rasilez (Tekturna in the US) was approved in the EU and the US in 2007 for treatment of hypertension as a monotherapy or in combination with other drugs. It is available in tablet form in all EU Member States except Estonia, Latvia, Lithuania and Romania.