EMA reviewing Novartis aliskiren-containing drugs

The European Medicines Agency is reviewing aliskiren-containing medicines, approved for the treatment of essential hypertension, to assess the impact of data coming from the ALTITUDE study on the balance of benefits and risks of these medicines in their approved indication.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) started the review after it was informed on December 19 by the marketing authorization holder, Swiss drug major Novartis (NOVN: VX), of the decision to terminate the ALTITUDE study with the firm’s Rasilez/Tekturna (aliskiren) early (The Pharma Letter December 21). This clinical trial included patients with type 2 diabetes and renal impairment and/or cardiovascular disease. In most patients arterial blood pressure was adequately controlled. The patients included in the trial received aliskiren in addition to either an angiotensin converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB).

Termination of the placebo-controlled Phase III trial was recommended by the independent Data Monitoring Committee overseeing the study, because the results showed that there was no benefit with aliskiren and that there were more cases of stroke, renal complications, hyperkalemia and hypotension in patients who received aliskiren compared with patients who received a placebo.