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Low-dose Prempro approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Wyeth plans early summer 2003 launch for low-dose formulation of Prempro (0.45 mg conjugated estrogens/1.5 mg medroxyprogesterone). The March 12 approval is based on the 2,805-patient HOPE study, which found the lower dose to be as effective as the 0.625 mg/2.5 mg dose in treating vasomotor symptoms and vaginal atrophy. The approval gives Wyeth the first positive news in hormone therapy since the Women's Health Initiative Prempro study arm was halted in July 2002 due to an increased risk of breast cancer and adverse cardiovascular outcomes. The firm is also pursuing a 0.3/1.5 formulation, with approval expected as early as Septembe
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