The European Medicines Agency has launched a review of Novartis’ hypertension drug Rasilez/Tekturna (aliskiren) after a clinical trial suggested the drug was linked to an increased risk of stroke and kidney problems.
The regulator has also recommended that diabetic patients should not be prescribed any aliskiren-containing medicines in combination with ACE inhibitors or angiotensin receptor blockers.
The bad news follows the announcement Novartis made earlier in the week that it was terminating the ALTITUDE clinical trial of aliskiren on the advice of an independent safety monitoring board. According to the results of the study, which included patients with type 2 diabetes and renal impairment and/or cardiovascular disease, there was no benefit with aliskiren and there were more cases of stroke, renal complications, hyperkalaemia and hypotension in patients who received the drug compared with those who received the placebo.
The EMA’s Committee for Medicinal Products for Human Use has requested additional information from Novartis so as to assess the impact of the results of the ALTITUDE trial on the overall benefit-risk profile of aliskiren-containing medicines and to determine the need for regulatory action.
Aliskiren had been touted as a sales driver for Novartis but the company this week said the drug is likely to be “negatively impacted” by the early termination of the trial while Novartis would cease promotion of Rasilez/Tekturna-based products for use in combination with an ACE-inhibitor or ARB.
“Patient safety is the highest priority for Novartis and we are in a dialogue with health authorities worldwide,” said David Epstein, division head of Novartis Pharmaceuticals.
The news and the regulators final decision could be a major blow for the drug major as there are eight aliskiren-containing medicines licensed for use in Europe including the triple-combo blood pressure pill Rasitrio (aliskiren/amlodipine/hydrochlorothiazide), which only received European approval less than a month ago.