US drug naker Merck & Co today said that it has received the approval of European regulator for Elnova, a fertility treatment injection, the first sustained follicle stimulant.
Merck, which acquired Schering-Plough in November 2009, said that it has gained the European Commission approval for Elnova (corifollitropin alfa injection).
Elnova is indicated 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) programme.
New Jersey-based Merck said that with the EC approval, it has received the marketing authorisation for Elnova for all European Union member states.
Elnova is the first sustained follicle stimulant. Due to its ability to initiate and sustain multiple follicular growth for an entire week, a single subcutaneous injection of the recommended dose of Elnova may replace the first seven injections of any conventional daily recombinant follicle stimulating hormone (rFSH) preparation in a COS treatment cycle.
''The European approval of Elnova is a positive step towards reducing the burden of injections for women experiencing difficulty conceiving,'' said Mirjam Mol-Arts, senior vice president, Merck Research Laboratories.