New hope for IVF couples

A new drug is offering hope to couples undergoing IVF.

The drug means women will no longer face a daily hormone injection, instead it will be a single dose each week.

IVF specialists say the drug will make the process more comfortable for women who now have to give themselves a daily injection for between seven and 10 days in a row to create eggs for collection.

The medical director of Melbourne IVF, Lyndon Hale, said an international study recently showed the drug Elonva delivered the same number of pregnancies and outcomes as the drug currently used. But he said this option was only suitable for about 80 per cent of women and not those with particular conditions, such as polycystic ovary syndrome.

The new treatment becomes available next month.

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).

Engage was a non-inferiority trial designed to compare Elonva 150 mcg to 200 IU rFSH. A total of 1,506 patients (with a body weight greater than 60 kg) at 34 in-vitro fertilization (IVF) clinics in North America and Europe were randomized to start stimulation with either Elonva 150 mcg or a daily dose of 200 IU rFSH for seven days. Patients also received rFSH (maximum 200 IU/day) from stimulation day eight onward, when required. Starting on stimulation day five, all patients received 0.25mg gonadotropin-releasing hormone (GnRH) antagonist until triggering of final oocyte maturation by human chorionic gonadotropin (hCG). The primary endpoint was the ongoing pregnancy rate assessed at ten weeks or more after embryo transfer. In the Elonva treatment arm the ongoing pregnancy rate (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 number of oocytes retrieved per attempt, the co-primary endpoint, was 13.7 (± 8.2) for the Elonva group and 12.5 (± 6.7) for the rFSH group.

Elonva is approved for COS in combination with a GnRH antagonist for the development of multiple follicles in women participating in an ART program. Elonva is designed as a sustained follicle stimulant with the same pharmacodynamic profile as rFSH, but with a markedly prolonged duration of FSH activity. 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 rFSH preparation in a COS treatment cycle. is approved for COS in combination with a GnRH antagonist for the development of multiple follicles in women participating in an ART program.

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'.