WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the New Drug Application (NDA) for its investigational fertility treatment, corifollitropin alfa, has been accepted for standard review by the U.S. Food and Drug Administration (FDA). Merck is seeking FDA approval of corifollitropin alfa for Controlled Ovarian Stimulation (COS) in women participating in assisted reproductive technology.
If approved, corifollitropin alfa would be the first sustained follicular stimulant for use in a fertility treatment regimen.
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Merck received approval on February 15, 2010 from the European Commission for ELONVA (corifollitropin alfa) a long lasting single injection fusion protein lacking LH activity. Only one injection is required for the first seven days, replacing the first seven daily injections of conventional FSH. Initial results demonstrates similar pregnancy rates as daily recombinant FSH injections.
- ref 7 N. P. Koper, R. Boostanfar, P. Devroey, B. C. Fauser, P. C. IJzerman-Boon, B. M. J. L. Mannaerts. Global ClinicalDevelopment, Organon, Part of Schering-Plough Corporation, Oss, Netherlands; Huntington Reproductive Center, Tarzana, CA; Center of Reproductive Medicine, Dutch-speaking Free University, Brussels, Belgium; University Medical Center Utrecht, Utrecht, Netherlands; Biometrics, NV Organon, Part of Schering-Plough Corporation, Oss, Netherlands. “Corifollitropin alfa demonstrates similar pregnancy rates as compared to daily recombinant FSH treatment in a controlled ovarian stimulation regimen for IVF/ICSI.” Fertility and Sterility, 90:page S75.
- ref 8 ^ Devroey P, Boostanfar R, Koper NP, Mannaerts BM, Ijzerman-Boon PC, Fauser BC, 2009. “A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol.” Human Reproduction, 2009, August 14, [Epub ahead of print]. PMID 19684043.
In May2013, MSD launched ELONVA® (corifollitropin alfa injection) – a new treatment for fertility, – in Singapore. Approved for controlled ovarian stimulation in combination with a GnRH antagonist for the development of multiple follicles, Corifollitropin alfa injection is the first sustained follicle stimulant. A single subcutaneous injection of the recommended dose of corifollitropin alfa injection may replace the first seven injections of any
Findings showed that other failed repeated treatments may lead to depression, anxiety, sexua conventional daily recombinant follicle stimulating hormone (rFSH) preparation in a controlled ovarian stimulation treatment cycle. Simplified fertility treatment with Elonva not only helps to reduce the emotional and physical burden of fertility, it may also reduce dropout rates and potentially improve the overall chances of pregnancy.
l anxiety/difficulty, relationship problems with partner, family and friends, increased sense of self-blame and guilt, particularly for the partner experiencing fertility problem. ”By reducing the number of daily injections, the
availability of corifollitropin alfa injection is a positive step towards helping reduce the burden of fertility treatment for women experiencing difficulty conceiving. Simplifying fertility treatment with new modalities of treatment and new medication may encourage more infertile couple to embark
on treatment earlier when the wife’s age is younger and ovarian reserve better.” said Dr Loh Seong Feei, Medical Director of Thomson Fertility Centre