Merck Serono, a division of Merck KgaA, Darmstadt, Germany, announced that the European Commission (EC) has granted an approval for three pre-filled, ready-to-use pen injectors for fertility treatment. This “family of pens” is designed for self-administration of the liquid formulations of its three recombinant gonadotropins used in fertility treatments: GONAL-f (follitropin alfa) 300 IU, 450 IU and 900 IU, Luveris (lutropin alfa) 450 IU and Ovidrel/ Ovitrelle 250 micrograms (choriogonadotropin alfa).
“Merck Serono is continuously working on improving its administration devices in order to meet patients’ and healthcare professionals’ needs”, said Dr Bharat Tewarie, senior vice president Global Business Unit Fertility and Metabolic Endocrinology at Merck Serono. “Fertility treatment specialists were involved from the beginning in the development of the new devices for the Merck Serono gonadotropins portfolio for fertility treatment. We are pleased to introduce today the specially designed injection devices that combine key features recommended by them.”
The newly approved pre-filled pens were designed to facilitate daily administration by patients during their fertility treatment. The pens immediately confirm that a complete dose was delivered, or indicate the missing amount if an incomplete dose is injected.
Other key features include a new graduated scale on reservoir for patients to check the amount of medication remaining in the pen and a bi-directional dose dial allowing them to correct the dose dialed, if needed, with a complete portfolio of gonadotropins, Merck Serono offers fertility specialists the ability to tailor treatment to patients’ needs. Since the birth of the first IVF baby, nearly 4.3 million babies worldwide have been born with help from in-vitro fertilization techniques. Merck Serono has helped thousands of infertile couples to realize their dream of becoming parents, and continues to seek new solutions that meet patients’ treatment needs.
The New GONAL-f pre-filled pens are approved and launched in Australia, New Zealand, Canada and Switzerland, and are approved in Europe. Ovidrel / Ovitrelle pre-filled pen is approved in Australia, New Zealand and Europe. Luveris pre-filled pen is approved in Australia, Canada and Europe.
Merck Serono is the world leader in fertility treatments, and the only company to offer a full portfolio of fertility drugs for every stage of the reproductive cycle and recombinant versions of the three hormones needed to treat infertility: GONAL-f (follitropin alfa), to stimulate the ovaries and produce eggs in women and spermatogenesis induction in men; Luveris (lutropin alfa), to stimulate follicular development in women who are profoundly LH deficient; Cetrotide (cetrorelix acetate) to prevent a premature ovulation; Ovitrelle (choriogonadotropin alfa), to help follicles mature and release eggs; and Crinone (progesterone gel), to help establish and maintain a pregnancy.
GONAL-f is a highly consistent recombinant human Follicle-Stimulating Hormone (r-hFSH) available in Filled by Mass (FbM) form, prescribed to supplement or replace naturally occurring FSH, an essential hormone to treat infertility.
With a complete portfolio of gonadotropins, Merck Serono offers fertility specialists the ability to tailor treatment to patients’ needs. Since the birth of the first IVF baby, nearly 4.3 million babies worldwide have been born with help from in-vitro fertilization techniques. Merck Serono has helped thousands of infertile couples to realize their dream of becoming parents, and continues to seek new solutions that meet patients’ treatment needs.
Luveris (lutropin alfa) is a recombinant human Luteinising Hormone (r-hLH) developed to support follicular growth in women with severe FSH and LH deficiency. In the body, LH causes the release of eggs (ovulation) during the menstrual cycle. Luveris is used together with FSH, which also stimulates ovulation. It is approved in more than 70 countries.
Ovitrelle/Ovidrel is the world’s first and only recombinant chorionic gonadotropin (r-hCG). It is administered after the stimulation for the growth of follicles (or eggs) by another hormone (FSH).
Merck Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical company. It discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications.