Novartis AG (NVS) Friday reported the conclusion of a risk-benefit review of its high blood pressure drug Rasilez by the European Medicines Agency's, or EMA's, Committee for Medicinal Products for Human Use, or CHMP. The Committee recommended that the product information for Rasilez in the EU should warn against use by patients who are also taking an ACE inhibitor or an ARB.
The review, which followed Novartis's decision to terminate its ALTITUDE study in the wake of a high incidence of adverse events, found that patients who have diabetes or mild-to-moderate renal impairment should consult a physician before using a combination product containing aliskiren, for which Rasilez is the trade name. The update also applies to other aliskiren products such as Sprimeo, Riprazo and Rasilamlo.
by RTT Staff Writer
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