Schering-Plough has announced that the European Medicines Agency has validated its marketing authorization application for corifollitropin alfa, the company's experimental, sustained follicle stimulant. This application will follow the centralized procedure.
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Corifollitropin alfa is being developed as a potential treatment in controlled ovarian stimulation (COS) for the development of multiple follicles and pregnancy in women participating in an assisted reproductive technology program.
Corifollitropin alfa is designed as a sustained follicle stimulant with the same pharmacodynamic profile as follicle stimulating hormone (FSH), but with a markedly prolonged duration of FSH activity, the company said. Due to its ability to initiate and sustain multiple follicular growth for an entire week, a single subcutaneous injection of the recommended dose of corifollitropin alfa may replace the first seven injections of FSH preparation in a COS treatment cycle.
If approved, corifollitropin alfa would extend Schering-Plough’s fertility portfolio, which also includes Puregon.
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