Merck & Co has reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended approval of Elonva (corifollitropin alfa injection).
Elonva is to be utilized 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) program.
The company said that if approved by the European Commission, Merck would receive marketing authorization for Elonva with unified labeling valid in all EU member states.
Elonva is a 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.
The phase III development program for Elonva included the engage trial, a double-blind fertility agent trial ever performed. The ongoing pregnancy rate, the primary endpoint of engage, in the Elonva treatment arm (38.9% per started cycle) was similar to that achieved in patients receiving a daily dose of rFSH for seven days (38.1% per started cycle).
Mirjam Mol-Arts, senior vice president of research laboratories at Merck, said: “Elonva will reduce the burden of injections for women experiencing difficulty conceiving, and the positive opinion is an important step toward a European approval. Elonva demonstrates Merck’s commitment to providing effective patient-focused fertility treatments.”