Merck KGaA. (11/13/17). "Press Release: Merck Receives FDA Approval for New Gonal-f Prefilled Pen [Not intended for U.S. and UK based media]". Darmstadt.

	Region	United States (USA)
	Organisation	Merck KGaA
	Group	Merck (DE) (Group)
	Organisation 2	FDA (US Food and Drug Administration)
	Group	United States (govt)
	Product	Gonal-F
	Product 2	drug delivery technology (drug formulation technology)
	Person	Rossetti, Luciano (Flagship Pioneering 202101– CMO + Head RnD of Pioneering Medicines before Merck (DE) + Merck (US))

> 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 patients, nurses and doctors helped 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.

“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

1. 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

2. Data on file. Market Data Analytics. September 2015

3. Data on file. IMS MIDAS database Q4 2016, May 2017

4. 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

Record changed: 2023-06-05