Merck announces FDA acceptance of New Drug Application for investigational fertility treatment
Posted: 9 September 2013 | | No comments yet
Merck announced that the NDA for its investigational fertility treatment, corifollitropin alfa, has been accepted for standard review by the U.S. FDA…
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the New Drug Application (NDA) for its investigational fertility treatment, corifollitropin alfa, has been accepted for standard review by the U.S. Food and Drug Administration (FDA). Merck is seeking FDA approval of corifollitropin alfa for Controlled Ovarian Stimulation (COS) in women participating in assisted reproductive technology.
If approved, corifollitropin alfa would be the first sustained follicular stimulant for use in a fertility treatment regimen.
“Infertility is an issue faced by many couples in the United States,” said Barbara Stegmann, M.D., reproductive endocrinology and infertility specialist, and principal scientist and clinical lead fertility, Merck. “The filing of corifollitropin alfa is an example of Merck’s commitment to patients and scientific innovation. We thank the patients and physicians who have participated in the clinical trials that are so essential to developing innovative fertility treatment options.”
Merck’s corifollitropin alfa is currently approved in more than 50 markets outside the United States, including the European Union.
