Ares-Serono Group announced Tuesday that it has filed a newdrug application (NDA) for Gonal-F with FDA. The recombinanthuman follicle stimulating hormone (FSH) is for use in womenundergoing in vitro fertilization and embryo transfer.
Ares-Serono of Geneva, Switzerland, conducted Phase III trialsof the drug in the U.S. and Europe. In October 1992 thecompany reported that the trials resulted in the birth of twinsin Switzerland, the first birth resulting from a recombinantinfertility treatment. Ares-Serono's U.S. subsidiary, SeronoLaboratories Inc., is in Norwell, Mass.
Fabio Bertarelli, chief executive officer of the Ares-SeronoGroup, said the company expects that Gonal-F will eventuallyreplace the urine-based products currently on the market.
FSH of urinary origin has been used to stimulate follicle andegg maturation for in vitro fertilization and embryo transfer inwomen who do not ovulate properly, and in men to initiate orimprove sperm production. -- Brenda Sandburg
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