Merck receives FDA approval for new fertility drug for women
21 Nov 2009
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended approval of US rug maker Merck & Co's new fertility treatment for women.
The new drug, Elonva (corifollitropin alfa injection) has been developed by Merck as a treatment in 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) programme.
Elonva is the first in the class of sustained follicle stimulants (SFS). Due to its ability to initiate and sustain multiple follicular growth for an entire week, a single subcutaneous injection of the recommended dose of Elonva may replace the first seven injections of any daily recombinant follicle stimulating hormone (rFSH) preparation in a COS treatment cycle.
Elonva is an investigational product being developed as a potential treatment in COS in combination with a GnRH antagonist for the development of multiple follicles in women participating in an ART programme. Elonva is designed as an SFS with the same pharmacodynamic profile as rFSH, 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 ELONVA may replace the first seven injections of any daily rFSH preparation in a COS treatment cycle.
If approved by the European Commission, Merck would receive marketing authorisation for Elonva with unified labelling valid in all European union countries.
