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news.Merck & Co has received the European Commission (EC) approval for 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.
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With the EC approval, Merck also receives marketing authorization for Elonva with unified labeling valid in all the EU member states.
Elonva is a sustained follicle stimulant capable of initiating and sustaining multiple follicular growth for an entire week. The company claims that 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.
Mirjam Mol-Arts, senior vice president of Merck Research Laboratories, said: “The European approval of Elonva is a positive step towards reducing the burden of injections for women experiencing difficulty conceiving. 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% per started cycle) was similar to that achieved in patients receiving a daily dose of rFSH (38.1% per started cycle).