The European Commission (EC) has granted marketing authorisation for Swiss-based Ferring Pharmaceuticals’ Rekovelle (follitropin delta), a human recombinant follicle stimulating hormone (human rFSH).
Rekovelle is used in controlled ovarian stimulation to develop multiple follicles in women who undergo assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
Derived from a human cell line, it is the first rFSH treatment to be administered with an individualised dosing regimen.
Ferring Pharmaceuticals president of executive board and Michel Pettigrew said: “Ferring has a long-standing commitment to scientific advancement in reproductive health.
“As a research-driven company, we believe that by focusing on innovative and personalised approaches, we can continue to lead the way in fertility treatments and help women to plan their futures as mothers.”
The individualised dosing regimen of Rekovelle is based on a woman’s serum anti-Müllerian hormone (AMH) level, as well as her body weight.
By predicting a woman’s ovarian response to gonadotrophin stimulation, it can also help guide the dosing of fertility treatments.
The EC approval is based on a clinical data package, including results from the Phase III ESTHER trials.
The randomised, assessor-blind, controlled, multicentre Phase III ESTHER trials involved patients in 11 countries, and more than 2,000 cycles of controlled ovarian stimulation.
Data revealed that individualised treatment with Rekovelle had similar results for the co-primary endpoints of ongoing pregnancy and implantation rates.