Merck receives EU approval for new infertility drug

The European Commission has granted approval of ELONVA, a first-in-class drug manufactured by White House Station pharmaceutical company, Merck. ELONVA is used for controlled ovarian stimulation in women embarking on IVF (in vitro fertilisation) treatment for infertility. With this approval, Merck has marketing authorisation for the drug in all EU member states.

Approximately 15 per cent of couples are considered to be affected by infertility. This can be due to a number of causes such as blocked Fallopian tubes or sperm ducts. Several treatment options are now available which may enable the couple to have children, including IVF. In IVF, mature eggs are removed from 'follicles' in the female ovary and fertilised outside the body by the sperm. Viable embryos are then replaced in the uterus of the female after which pregnancy may result.

In order to increase the chances of a viable embryo being produced, multiple follicles are stimulated to mature at once in a process called superovulation. Typically the woman undergoes several injections of a hormone called 'follicle stimulating hormone' (FSH) on a daily basis. ELONVA has the same pharmacological properties to FSH, with the advantage that the stimulatory effects of ELONVA are maintained over an entire week post-injection; it is a first-in-class of sustained follicle stimulants (SFS). Consequently a single subcutaneous injection of the recommended dose of ELONVA may replace the first seven injections of any daily FSH preparation in a treatment cycle. After the first week of treatment, FSH is given on a daily basis until follicles are ready to be removed. In a trial of more than 1500 couples undergoing IVF, the pregnancy rates of those receiving ELONVA followed by FSH compared to women receiving only FSH were comparable.

'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 of Merck Research Laboratories, adding: 'ELONVA demonstrates Merck's commitment to providing effective patient-focused fertility treatments and extends the company's leadership in this therapy area'.