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 cent per started cycle) was similar to that achieved in patients receiving a daily dose of rFSH (38.1 per cent per started cycle).