Merck Serono Announces US FDA Approval for Fertility Pen
DARMSTADT, Germany, October 18, 2013 /PRNewswire/ --
- Gonal-f®RFF Redi-ject™ follitropin alfa injection) redesigned to incorporate patient and provider feedback
Merck Serono, the biopharmaceutical division of Merck, today announced that the U.S. Food and Drug Administration (FDA) granted approval to its subsidiary, EMD Serono, Inc., for Gonal-f®RFF Redi-ject™ (follitropin alfa injection), a disposable pre-filled drug injector pen intended for the subcutaneous injection of a liquid formulation of Gonal-f® RFF (Revised Formulation Female).
Gonal-f® RFF Redi-ject™ is part of a global family of prefilled pens designed for patient self-administration of Gonal-f® with demonstrated dose accuracy and designed with physicians and patients in mind.[1] Gonal-f® (recombinant follitropin alfa for injection) is prescribed to supplement or replace naturally occurring follicle-stimulating hormone (FSH), an essential hormone to treat infertility, and as the world's first recombinant human follicle-stimulating hormone (r-hFSH), it has an 18-year heritage of proven clinical experience around the world.[2]
Since the birth of the first IVF baby, nearly 5 million babies worldwide have been born with help from in-vitro fertilization techniques.[3]
"With a complete portfolio of gonadotropins, Merck Serono is continuously innovating to improve its administration devices in order to meet the needs of patients and healthcare professionals," said Annalisa Jenkins, Global Head of Research & Development at Merck Serono. "We have a strong legacy in fertility, and the approval of the Gonal-f® RFF Redi-ject™ in the U.S. further demonstrates our commitment to building our leadership position in this important therapeutic area as we look to the future. We will continue to pioneer innovative science that advances our goal of improving pregnancy outcomes and take home baby rates."
The Gonal-f® RFF Redi-ject™ will be available in the U.S. in December 2013 in three pen sizes: 300 IU, 450 IU and 900 IU. The Gonal-f® prefilled pens are approved and launched in 64 countries around the world.
References:
- Christen et al. Expert Opinion in Drug Delivery 2011.
- European Medicines Agency. EPAR Summary for the Public. GONAL-f®. 2010.
- The European Society of Human Reproduction and Embryology. http://www.eshre.eu/ESHRE/English/Press-Room/Press-Releases/Press-releases-2012/ESHRE-2012/5-million-babies/page.aspx/1606. Last accessed 07/06/13.
About GONAL-f®
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.
GONAL-f® has been approved in 100 countries worldwide - among which 74 countries have approved GONAL-f® prefilled pen - including Europe and the US with indications of stimulation of the growth of ovarian follicles and ovulation in women. It is the most widely prescribed gonadotropin in the world. For males, GONAL-f® has been approved in 77 countries worldwide, including Japan, for gonadal dysfunction associated with absence of sperm in the semen or male hypogonadotropic hypogonadism. In certain markets where GONAL-f® is approved for this indication, the therapy needs to be in combination with human Chorionic Gonadotropin (hCG).
In the US, GONAL-f® Multi-Dose, available as the GONAL-f® 1050 IU vial or GONAL-f® 450 IU vial is indicated for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure as well as for ovulation induction and the development of multiple follicles in the ovulatory female patient participating in an Assisted Reproductive Technology (ART). GONAL-f® RFF Pen and 75 IU vial is approved for women only in the US.
Important: GONAL-f® (follitropin alfa for injection) should only be prescribed by physicians specializing in fertility or reproductive health. As all medicines, GONAL-f® is a potent gonadotropic substance capable of causing mild to severe adverse reactions, including: Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications, and multiple births. GONAL-f® is contraindicated in patients who exhibit prior hypersensitivity to FSH preparations and tumours of the hypothalamus or the pituitary gland. It is also contraindicated for women with ovarian enlargement or ovarian cyst of unknown aetiology, Gynaecological haemorrhages of unknown aetiology and ovarian, uterine or mammary carcinoma. Nursing women should not use GONAL-f®. Common side effects in women include OHSS, ovarian cysts, headache, abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting, diarrhoea and injection site disorders. For complete product details, see full prescribing information.
About Merck Serono
Merck Serono is the biopharmaceutical division of Merck. With headquarters in Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. In the United States and Canada, EMD Serono operates as a separately incorporated subsidiary of Merck Serono.
Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurology, oncology, immuno-oncology and immunology.
For more information, please visit http://www.merckserono.com.
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About Merck
Merck is a leading pharmaceutical, chemical and life science company with total revenues of € 11.2 billion in 2012, a history that began in 1668, and a future shaped by approx. 38,000 employees in 66 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.
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