Gonalef filed for female infertility in Japan
This article was originally published in Scrip
Executive Summary
Merck Seronohas submitted an approval application in Japan for the recombinant human follicle-stimulating hormone product Gonalef (follitropin alfa) for the additional indication of induction of ovulation in infertile women. The filing includes data from a local Phase III study in women with no or irregular ovulation or polycystic ovary syndrome. Gonalef (also marketed elsewhere as Gonal-f) was first launched in Japan in 2006 for infertility in men with hypogonadotropic hypogonadism, for which it is used in combination with human chorionic gonadotropin.