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.
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This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.