Merck KGaA announced today that the Japanese Ministry of Health, Labor and Welfare has granted approval to extend the indication of Gonal-f® (follitropin alfa for injection) to infertile women suffering from irregular or no ovulation (oligoovulation or anovulation) due to a dysfunction in the hypothalamic-pituitary system or polycystic ovarian syndrome. Gonal-f is a recombinant follicle-stimulating hormone currently approved in Japan for the treatment of male infertility.
The extended marketing authorization includes Gonal-f in 75 IU (International Units) vial and Gonal-f prefilled pen in 300 IU, 450 IU and 900 IU.
In Japan, Gonal-f has been indicated since 2006 to treat male hypogonadotropic hypogonadism (MHH) in combination with human Chorionic Gonadotropin (hCG), for the induction of spermatogenesis. The supplemental New Drug Application (sNDA) for ovulation induction in females was filed by Merck Serono in October 2008.
GONAL-f is currently approved in 77 countries for the treatment of male infertility and in 100 countries to treat female infertility.