EMEA's CHMP recommends approval of Merck's ELONVA

Merck & Co., Inc. today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended approval of ELONVA® (corifollitropin alfa injection) 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. If approved by the European Commission, Merck would receive marketing authorization for ELONVA with unified labeling valid in all European Union Member States.

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 will reduce the burden of injections for women experiencing difficulty conceiving, and the positive opinion is an important step toward a European approval," said Mirjam Mol-Arts, senior vice president, Merck Research Laboratories. "ELONVA demonstrates Merck's commitment to providing effective patient-focused fertility treatments and extends the company's leadership in this therapy area."

The Phase III development program for ELONVA included the Engage trial, the largest double-blind fertility agent trial ever performed. The ongoing pregnancy rate, the primary endpoint of Engage, in the ELONVA treatment arm (38.9 percent per started cycle) was similar to that achieved in patients receiving a daily dose of rFSH for seven days (38.1 percent per started cycle).