February 2, 2010 — The European Commission (EC) has approved corifollitropin alfa subcutaneous injection (Elonva, Merck and Company, Inc), the first sustained follicle stimulant.
Corifollitropin is indicated for controlled ovarian stimulation (COS) in combination with a gonadotropin-releasing hormone antagonist for the development of multiple follicles in women participating in an assisted reproductive technology program.
The long-acting carboxy terminal peptide–modified version of follicle-stimulating hormone (FSH) can be used to replace the first 7 injections of any conventional daily recombinant FSH (rFSH) preparation in a COS cycle.
“This is very exciting news, as this drug represents the first long-acting fertility drug currently approved for use,” Hilton I. Kort, MD, a founding partner of Reproductive Biology Associates in Atlanta, Georgia, told Medscape Ob/Gyn & Women’s Health. “Traditionally, fertility drugs for assisted reproductive technology require daily injections for 8 to 12 days combined with frequent blood tests and ultrasounds to monitor the patient’s response to the medication. The new drug will replace the first 7 days of injections and reduce the frequency of monitoring and associated costs.” Dr. Kort has worked in the field of infertility and in vitro fertilization for more than 30 years.
EC approval was based on data from the largest double-blind fertility agent trial performed to date (ENGAGE; n = 1506; participants < 37 years). The trial showed that the ongoing pregnancy rate was similar for patients receiving a single injection of 150 μg corifollitropin and those given 200 IU rFSH daily during the first week of a COS cycle (38.9% vs 38.1%).
The number of oocytes retrieved per attempt was likewise similar between groups (13.7 ± 8.2 vs 12.5 ± 6.7), as was the mean number of good-quality embryos obtained at days 3 and 5, respectively (4.6 ± 4.3 vs 4.4 ± 3.9; 2.6 ± 3.3 vs 2.6 ± 3.1).
Further analysis revealed that both regimens achieved similar oocyte/embryo quality, as well as consistently high pregnancy outcomes regardless of fertilization procedure (IVF or intracytoplasmic sperm injection), number of embryos transferred (single or double), or day of embryo transfer (day 3 or 5).
“The ENGAGE trial, completed in the United States and Europe, demonstrated that the new drug is as effective as the traditional daily injections,” Dr. Kort said.
Comment from Leslie
Hmmm, let’s see the Gardasil girls are no longer ovulating and all are having endocrine system problems – an now Merck is coming out with an ovulation stimulating drug? I think that all of these girls would like to have their menstrual cycles back. And that Merck would be one less pharmaceutical company.