PregLem's Esmya positive in Phase III for uterine fibroids
This article was originally published in Scrip
Executive Summary
PregLem's lead product, the oral progesterone receptor modulator Esmya (ulipristal acetate), has met the primary endpoint in a Phase III non-inferiority study (PEARL II) comparing it with leuprorelin for the treatment of symptomatic uterine fibroids (myoma). Leuprorelin, a gonadotropin-releasing hormone agonist, is the only pharmaceutical treatment currently approved for the condition and is delivered via monthly subcutaneous injection.