DARMSTADT, Germany, November 13, 2017 /PRNewswire/ --
- New pen is easy - to - learn and easy - to - use, supporting the
one in six couples affected by infertility in the U.S. [ 1 ]
- Insights of p atients, nurses and doctors help ed to
evolve the product
Merck, a leading science and technology company, today announced that the company received approval for a new version of
GONAL-f ® (follitropin alfa injection) prefilled pen from the U.S. Food and Drug Administration (FDA). Known as
GONAL-f ® RFF Redi-jectTM* prefilled pen in the U.S. and originally approved by the FDA in
2013, the new version of the pen is easy-to-learn and easy-to-use.
(Photo: http://mma.prnewswire.com/media/602538/Merck_New_Pen.jpg )
"Aspiring to be an integrated fertility treatment partner, our strategy focuses on developing user-friendly treatment options
for patients," said Luciano Rossetti, Head of Global Research and Development, at the biopharma
business of Merck. "We understand that the best drivers for innovation come from insights from the people using our products.
Their advice was a significant factor in the development of the new version of the GONAL-f ® prefilled
pen."
To date, an estimated 2.5 million babies have been brought to the world with the help of Merck fertility products and
services.[ 2 ] GONAL-f ® is the only gonadotropin that comes in
prefilled, ready-to-use pen in the U.S.[ 3 ] The new GONAL-f ® pen,
like its predecessor, enables a fine-tuning of treatment allowing for minimum increments of 12.5 IU to titrate a wide range of
doses and precisely target the dosing to patients' needs.[ 4 ] In addition, its new design
features include an amendment to the dose display window for readability.
Patients suffering from infertility are a key focus for Merck as the company continuously seeks to expand its fertility
offering. The latest version of the
GONAL-f ® prefilled pen is the most recent addition to Merck's growing portfolio to support women and couples
faced with infertility in the U.S., where one in six couples is affected by infertility.[ 1
]
References
- Thoma, M.E. et al. Prevalence of infertility in the United States as estimated by the
current duration approach and a traditional constructed approach. Fertility and Sterility 2013 9 (5):1324-1331
- Data on file. Market Data Analytics. September 2015
- Data on file. IMS MIDAS database Q4 2016, May 2017
- GONAL-f ® prefilled pen, Instructions for use. EU product information for GONAL-f ®
solution for injection in a prefilled pen. December 2015
*Revised Formulation Female
About GONAL- f ®
GONAL-f ® (follitropin alfa injection) is a recombinant human follicle-stimulating hormone (r-hFSH) approved
for the treatment female infertility and a rare form of male infertility. It is prescribed to supplement or replace naturally
occurring follicle-stimulating hormone (FSH), an essential hormone to treat infertility. GONAL-f ® has been
approved for use in the treatment of infertility in Europe since 1995 and since 1997 in
the United States, and is available in more than 100 countries worldwide. It is the most widely
prescribed gonadotropin in the world. Not all indications are approved in all markets for all product offerings.
Our Pens
Our pens consist of prefilled ready-to-use pens for GONAL-f ® 300 IU, 450 IU, and 900 IU, and
OVITRELLE®/OVIDREL® 250 mcg and Pergoveris® 300IU, 450IU and 900IU. The pens were developed
based on feedback from healthcare professionals and those experiencing fertility problems, in order to ease the teaching,
learning and use of the pens. Not all products are approved in all markets.
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About Merck
Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000
employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer
or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD
televisions. In 2016, Merck generated sales of € 15.0 billion in 66 countries.
Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority
owner of the publicly listed corporate group. Merck, Darmstadt, Germany holds the global rights
to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.
Contact: Dr. Raphaela Farrenkopf, +49-6151-72-2274
(Logo: http://photos.prnewswire.com/prnh/20160913/406891LOGO )