Merck’s Hyzaar Approved For Stroke Prevention
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA approval is based on results of the LIFE outcomes study; Cozaar was approved for same indication in March 2003. Like Cozaar, the benefit of Hyzaar in stroke prevention does not appear to be applicable to black patients, labeling says.
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Merck's angiotensin II receptor blocker Hyzaar can be marketed for the prevention of stroke following FDA approval of the supplemental indication. Hyzaar, a fixed-dose combination of losartan and hydrochlorothiazide, cleared FDA April 5 for use in stroke prevention based on the results of the LIFE outcomes study. Cozaar (losartan) was approved for the same indication in March 2003. Like Cozaar, Hyzaar is now indicated "to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy," 1 labeling says. Merck submitted NDA 20-387/S-033 on July 7, 2004. Hyzaar is also approved for use in treating hypertension, and was cleared by FDA for initial use in severe hypertension in 2004 (2 (Also see "Merck's Hyzaar Adds Front-Line Severe Hypertension Indication" - Pink Sheet, 6 Aug, 2004.)). FDA based the Hyzaar approval on the efficacy of Cozaar and the diuretic hydrochlorothiazide in the LIFE study, as well as Merck's ability to demonstrate that the losartan and hydrochlorothiazide tablets used in LIFE were bioequivalent to Hyzaar, Merck said. The 9,193-patient LIFE study evaluated the safety and efficacy of once-daily doses of either losartan 50 mg or atenolol 50 mg. Patients not reaching their blood pressure goals (less than 140/90 mmHg) also received hydrochlorothiazide 12.5 mg, and, if needed, increased their daily doses of losartan or atenolol to 100 mg. Treatment with losartan resulted in a 13% reduction in the risk of first occurrence of cardiovascular death, nonfatal stroke or nonfatal myocardial infarction, labeling says. Losartan reduced the risk of stroke by 25% relative to atenolol. As with Cozaar, there is no evidence that the benefit seen with Hyzaar is applicable to black patients. "Black patients treated with atenolol were at lower risk of experiencing the primary composite endpoint compared with black patients treated with losartan," labeling says. Cozaar and Hyzaar labeling were also recently revised to include an ARB class warning on rhabdomyolysis. The Adverse Reactions section also now includes rare reports of thrombocytopenia under a supplemental NDA approved April 12. - Kate Rawson |