Merck & Co., Inc., which operates outside the U.S. and Canada as MSD, today announced the European Commission (EC) approval of ELONVA® (corifollitropin alfa injection). ELONVA 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) program. With the EC approval, Merck receives marketing authorization for ELONVA with unified labeling valid in all European Union Member States. Schering-Plough Corp. and Merck & Co., Inc. merged on Nov. 3, 2009.
ELONVA 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 ELONVA 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 ELONVA 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. “Merck is proud of the company’s women’s health portfolio and is committed to providing effective patient-focused fertility treatments.”
The Phase III development program for ELONVA included the Engage trial, the largest double-blind fertility agent trial in IVF performed to date. In the Engage trial, the ongoing pregnancy rate, the primary endpoint, obtained in the ELONVA treatment arm (38.9 percent per started cycle) was similar to that achieved in patients receiving a daily dose of rFSH (38.1 percent per started cycle).
The most frequently reported adverse drug reactions during treatment with ELONVA in clinical trials are Ovarian Hyperstimulation Syndrome (OHSS) (5.2%), pelvic pain (4.1%) and discomfort (5.5%), headache (3.2%), nausea (1.7%), fatigue (1.4%) and breast complaints (including tenderness) (1.2%). Use with GnRH agonists is not recommended.