Corifollitropin alfa, a sustained follicle stimulant, extends options for patients and Schering-Plough's leadership in fertility Schering-Plough Corp., a leading provider of fertility treatments, announced that the European Medicines Agency (EMEA) has validated (accepted for review) its Marketing Authorization Application (MAA) for corifollitropin alfa, the company's experimental, sustained follicle stimulant (SFS). This application will follow the centralized procedure.
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 (ART) programme. Corifollitropin alfa is designed as a sustained follicle stimulant with the same pharmacodynamic profile as (recombinant) Follicle Stimulating Hormone (FSH), but with a markedly prolonged duration of FSH activity. 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 (recombinant)FSH preparation in a COS treatment cycle.
If approved, corifollitropin alfa would extend Schering-Plough's leading fertility portfolio, which also includes Puregon.
The most frequently reported adverse drug reactions during treatment with corifollitropin alfa in clinical trials are Ovarian Hyperstimulation Syndrome (OHSS), pelvic pain and discomfort, headache, nausea, fatigue and breast complaints (including tenderness). They are reported with an incidence between 1% and 6%.
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription, animal health and consumer healthcare products.