Merck's Cozaar Approved In The USA

23 April 1995

Merck & Co's new angiotensin II inhibitor Cozaar (losartan potassium) has been approved by the US Food and Drug Administration for the management of patients with hypertension. Merck will position the drug as having the efficacy of ACE inhibitors and a cleaner side-effect profile.

Losartan has been approved for the first-line treatment of hypertension alone or in combination with other agents. Labeling for the product notes that the incidence of side effects was similar to that seen with placebo, and that discontinuation of therapy due to clinical adverse experiences was required in 2.3% of patients treated with Cozaar and 3.7% of patients given placebo. The company notes that the drug has a markedly lower level of cough than ACE inhibitors, and also causes fewer headaches and edema.

This is the third approval for losartan after it was cleared in Sweden and the UK (Marketletters passim). Merck filed the New Drug Application for the drug in the USA on December 3, 1993. Analysts have estimated that the drug could generate sales of $200 million to $500 million annually at peak, although this will depend greatly on whether patients and doctors find the drug significantly better than ACE inhibitors.

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