Schering-Plough announces European submission of fertility medicine Corifollitropin Alfa

Schering-Plough Corp. has 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) program. 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(R).

Corifollitropin alfa Important Safety Information

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%.

PUREGON(R) Important Safety Information

Always use PUREGON exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Do not use PUREGON if you:

• are allergic (hypersensitive) to follitropin beta or any of the other ingredients of PUREGON
• have a tumour of the ovary, breast, uterus, testis, pituitary gland or hypothalamus
• are pregnant or breast-feeding
• have heavy or irregular vaginal bleeding where the cause is not known
• suffer from primary ovarian failure
• have ovarian cysts or enlarged ovaries not caused by polycystic ovarian disease (PCOD)
• have malformations of the sexual organs which make a normal pregnancy impossible
• have fibroids in the uterus which make a normal pregnancy impossible.  

Take special care with PUREGON