EMA recommends restrictions to Novartis' Rasilez

The European Medicines Agency (EMA) has completed a review of Novartis' renin inhibitor Rasilez/Tekturna, recommending changes to its labelling to reflect safety concerns when it is used alongside certain other drugs for high blood pressure.

The decision comes on the back of data from the ALTITUDE study, which revealed that adding Rasilez (aliskiren) to an ACE inhibitor or angiotensin II receptor blocker (ARB) caused certain safety risks.

These included an increase in the rate of non-fatal stroke, renal complications, high blood pressure and elevated blood potassium levels after 18-24 months' treatment.

Novartis had already said that doctors should not prescribe drugs containing aliskiren alongside ACE inhibitors or ARBs, and the EMA's Committee for Medicinal Products for Human Use (CHMP) has now followed that up with a recommendation for a formal change to the product's labelling to reflect that advice.

The CHMP also says there should be contraindications against aliskiren's use in patients with diabetes or kidney problems on ACE inhibitors or ARBs.

The recommendations go to the European Commission for a final decision, but Novartis has already said that it will change the labelling in accordance with the EMA's verdict.

"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," said David Epstein, division head of Novartis Pharmaceuticals, in a statement.

The CHMP has also requested an update to the product information of Rasilez and combination products containing aliskiren available in the EU.

The results of the ALTITUDE study caused real concerns for Novartis, which had hoped that Rasilez would achieve blockbuster status at peak.

At the time of the ALTITUDE findings were announced Novartis said the drug was not yet profitable, despite being launched in 2007.

Since then, Novartis' fourth-quarter results statement has indicated that the firm accrued $903m in exceptional charges related to Rasilez and expects sales of the drug to halve in 2012 compared to 2011, when it brought in $557m.