EMD Serono wins FDA nod for redesigned pen injector

Merck KGaA‘s biopharma biz, EMD Serono, said today that it won FDA approval for a redesigned version of its Gonal-f RFF Redi-ject pen injector.

The device, which was first approved in 2013, is designed to inject follitropin alfra to induce ovulation and pregnancy in oligo-anovulatory women. The newly-designed pen was evaluated in a simulated-use study involving 86 women with infertility and 30 fertility nurses.

The company touted its device as the only pen injector for a fertility drug that does not require mixing or loading. The redesigned pen also features a larger display window.

“As a committed fertility treatment partner, we aspire to develop user-friendly treatment options for patients,” Richard Smith, EMD Serono’s SVP & head of U.S. fertility and endocrinology, said in prepared remarks. “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.”

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Last Chance to Save for DeviceTalks Boston! Early rates for DeviceTalks Boston end August 15th. Don't miss the chance to save $100 and join top medtech innovators including leaders from Hologic, Google, Gray Matter, TransEnterix, NxStage Medical, Smith & Nephew, HeartFlow, Dynatronics, Johnson & Johnson, Allied Minds, and many more. View Full Agenda Register today to save. Use code LASTCALL to save an additional 10%.