Thursday, 7 October, 2010
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.