FDA Reviews Fertility Drug, Corifollitropin Alfa
Merck announced that the FDA has accepted for review its New Drug Application (NDA) for the investigational fertility treatment, corifollitropin alfa for Controlled Ovarian Stimulation (COS) in women participating in in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). Corifollitropin alfa is a long-acting follicle-stimulating hormone (FSH) agonist.
Corifollitropin alfa has been studied in the PURSUE study, a randomized, double-blind, double-dummy, active controlled, non-inferiority trial assessing the vital pregnancy rate in 1,390 women.
If approved, corifollitropin alfa would be the first sustained follicular stimulant for use in a fertility treatment regimen.For more information call (800) 672-6372 or visit Merck.com.