Ferring has a long-standing commitment to scientific advancement in reproductive health. | File photo
+ Regulatory
Keri Carbaugh | Dec 27, 2016

E.U. grants approval for REKOVELLE by Ferring

Marketing authorization for REKOVELLE (follitropin delta) was granted this month by Ferring Pharmaceuticals.

REKOVELLE is used in controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART). It is a one-of-its-kind treatment, the first human recombinant follicle stimulating hormone (rFSH), and the first to have an individualized dosing regimen based on a woman’s serum anti-Mullerian hormone (AMH) level and her weight.

“REKOVELLE’s individualized dosing regimen offers physicians a new method to deliver a consistent, evidence-based approach to personalizing treatment for their patients, based on AMH, a highly predictive biomarker,” Anders Nyboe Andersen, principal investigator of the Evidence-based Stimulation Trial with Human rFSH (ESTHER) trials, said.

Using validated protocols for individualization could help physicians facilitate the best possible outcomes for their patients by ensuring efficacy is maintained while also reducing complications during treatment.

“Ferring has a long-standing commitment to scientific advancement in reproductive health,” Michel Pettigrew, Ferring Pharmaceuticals' president of the executive board, said. “As a research-driven company, we believe that by focusing on innovative and personalized approaches, we can continue to lead the way in fertility treatments and help women to plan their futures as mothers.”

Organizations in this story

More News