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EU, Canada probe Rasilez safety after study termination

Investigation after Novartis drug linked to high levels of adverse events in high-risk patient trial

The European Medicines Agency (EMA) and Canada's Health Protection Board have started a review of drugs based on Novartis' renin inhibitor aliskiren after the company pulled the phase III ALTITUDE study on safety concerns.

Earlier this week Novartis said the study of Rasilez in diabetic patients with renal impairment suggested its drug may be linked to higher levels of adverse events when added to standard treatment with an ACE inhibitor or angiotensin II receptor blocker.

These events included non-fatal stroke, renal complications, high blood pressure and elevated blood potassium levels.

As a result Novartis has already recommended that doctors do not prescribe drugs containing aliskiren alongside ACE inhibitors or ARBs, and that patients who are already doing so should be switched to alternative treatment.

The EMA said its Committee for Medicinal Products for Human Use (CHMP) started the review after it was informed on December 19 of the decision to terminate the ALTITUDE study early.

"The information available at present is limited," said the EMA in a statement yesterday, adding it has asked the company to provide additional analyses.

This extra information would allow the CHMP 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."

There are eight aliskiren-containing medicines authorised in the EU, according to the agency, although five of these are combinations of aliskiren with other drugs - such as amlodipine and hydrochlorothiazide - which are not directly affected by the issues raised in the ALTITUDE study.

Sales of Rasilez were on target to reach around $600m in 2011, but analysts have suggested that earlier hope of blockbuster revenues have now been dashed.

Deutsche Bank said in the wake of Novartis' announcement that up to 1,000 jobs may be lost at the pharma company as a result of the disappointment.

23rd December 2011

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