FDA Approves Pre-Filled Pre-Mixed Fertility Medication

Mar 24 2004

The U.S. Food and Drug Administration (FDA) today announced approval of Follistim®-AQ ^TM cartridge (follitropin beta injection) in the United States. Follistim-AQ cartridge is the first follicle stimulating hormone (FSH) treatment available in a pre-filled, pre-mixed solution, eliminating the need for patients to mix one or more vials of medication.

Follistim-AQ cartridge is designed to be used only with the Follistim® Pen^TM, an innovative pen device that facilitates accurate delivery of individualized doses of pre-mixed follitropin beta injection, a highly effective and widely used prescription fertility medication.

Follistim is prescribed for women undergoing assisted reproductive treatments (ART) such as in vitro fertilization (IVF), and for the induction of ovulation to achieve pregnancy. Follistim-AQ cartridge, used with the Follistim Pen, provides women with a discreet, convenient method to self-administer fertility treatment with ease and confidence using the unique dial-a-dose feature. Organon USA Inc. markets Follistim-AQ cartridge and Follistim Pen. In Europe it is marketed under the brand name Puregon® Pen^TM.

“Fertility treatment can be of concern for patients, in large part because they have to mix, measure and inject the medicine themselves,” said Samuel Pang, MD, Associate Medical Director, Reproductive Science Center of Boston, and an investigator in the Follistim-AQ cartridge/Follistim Pen clinical trials. “This innovative method of delivering FSH makes the process go much more smoothly, because the medicine is already mixed and the patient just has to dial the correct dose. Also, the micro needle and small volume of medication may contribute to patient tolerability of the injection.”

Organon is pleased that the FDA has approved Follistim-AQ cartridge for patients experiencing infertility,” said Michael Novinski, President, Organon Pharmaceuticals USA Inc. “The introduction of Follistim-AQ cartridge, enhances Organon’s position as a leader in the development, production and marketing of innovative, patient friendly fertility treatment.”

Results of clinical studies have shown that self-injection with Follistim-AQ cartridge, for use with Follistim Pen, is safe, convenient and well tolerated by patients. According to a recent study conducted by Samuel Pang, MD et al. ¹, the lead author for the Follistim Pen COH Study Group, of the 60 women who participated in the study 59 (98.3%) rated the overall experience of self-injecting with the Follistim Pen as “very good” to “good.”

Infertility affects about six million American couples, approximately 10 percent of the reproductive age population. The U.S. Centers for Disease Control reported there were nearly 110,000 cycles of assisted reproductive technology in the year 2001.

Internet: www.organon.usa.com; www.follistim.com