Single fertility treatment with Merck & Co's Elonva produced live birth rates comparable to daily rFSH Injections

US drug giant Merck & Co's subsidiary MSD has announced findings from a follow-up study to the pivotal Engage Phase III trial. Treatment with a single Elonva (corifollitropin alfa) injection had comparable live birth rates with daily recombinant follicle stimulating hormone (rFSH) injections for the first week of stimulation. Elonva was cleared for marketing in Europe in January.

All patients were treated with a GnRH antagonist. These latest efficacy findings are from a follow-up study of the largest double-blind fertility agent trial performed in in-vitro fertilization (IVF) to date. In the follow-up study, patients with ongoing pregnancies were followed up to delivery. In a combined analysis of safety data from the Engage and Ensure trials (the Care program), there were no differences in neonatal outcome or congenital malformation rates between weekly corifollitropin alfa injection and daily rFSH injections. These new data were presented yesterday at the 2010 European Society of Human Reproduction and Embryology (ESHRE) annual meeting in Rome, Italy.

Corifollitropin alfa injection, the first and only sustained follicle stimulant, is approved in Europe for controlled ovarian stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (ART) program. Due to its ability to initiate and sustain multiple follicular growth for an entire week, a single subcutaneous injection of the recommended dose may replace the first seven injections of any conventional daily rFSH preparation in a COS treatment cycle.