Schering-Plough has announced that the European Medicines Agency has accepted for review its marketing authorisation application for corifollitropin alfa.
The company noted that the drug, a sustained follicle stimulant, 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” programme.
S-P said that corifollitropin alfa, which was acquired through its $14.4 billion acquisition of Organon Biosciences in 2007 from Akzo Nobel, is designed with the same pharmacodynamic profile as recombinant follicle stimulating hormone (rFSH), but with a markedly prolonged duration of FSH activity. The firm added that due to its ability to initiate and sustain multiple follicular growth for an entire week, a single subcutaneous injection of corifollitropin alfa may replace the first seven injections of rFSH preparation in a COS treatment cycle.
If approved, S-P said that corifollitropin alfa would extend its leading fertility portfolio, which is currently headed by Puregon (follitropin beta).
