EMD Serono, Merck KGaA’s U.S. and Canada-based biopharmaceutical business, recently received Food and Drug Administration approval for a redesigned version of a pen injector, designed to be used to induce ovulation and pregnancy in certain oligo-anovulatory women.
The GONAL-f RFF* Redi-ject (follitropin alfa injection) pen was first approved by the FDA in October 2013, according to a press release. The new version was found easier to use by 86 women with infertility and 30 fertility nurses during a simulated-use study, and the participants found it easy to learn how to use the product.
"As a committed fertility treatment partner, we aspire to develop user-friendly treatment options for patients," Richard R. Smith, senior vice president and head of U.S. Fertility and Endocrinology at EMD Serono, said in a statement. "The best drivers for innovation come from the insights of people using our products, which is why feedback from patients and healthcare professionals was critical in redesigning the pen injector features."
According to the company, infertility affects 1 in every 8 couples in the United States.
