The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has concluded that the risk–benefit balance of Rasilez® remains positive for essential hypertension.
The CHMP has requested that the product information of Rasilez (aliskiren) and combination products be updated.
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), the CHMP said.
The product information should also include a warning against the use of Rasilez and aliskiren-combination products in patients taking an ACE inhibitor of ARB.
“This decision comes after extensive interactions between Novartis and the CHMP,” said David Epstein, Division Head of Novartis Pharmaceuticals.
“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,” he continued.
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.
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.