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news.Ferring Pharmaceuticals has secured marketing authorisation from the European Commission (EC) for REKOVELLE (follitropin delta), a human recombinant follicle stimulating hormone (human rFSH), intended to be used in controlled ovarian stimulation for developing multiple follicles in women undergoing assisted reproductive technologies (ART), like an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
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REKOVELLE is the first rFSH to be derived from a human cell line and is the first rFSH treatment to be administered with an individualised dosing regimen. REKOVELLE’s individualised dosing regimen is based on a woman’s serum anti-Müllerian hormone (AMH) level and her body weight.
With these parameters, a specific daily dose of REKOVELLE is determined for each patient from the start of the ART cycle. AMH has surfaced as one of the most reliable biomarkers for assessing ovarian reserve.It can help predict a woman’s ovarian response to gonadotrophin stimulation and can also help guide the dosing of fertility treatments.
AMH will be measured by a companion diagnostic, the Elecsys AMH Plus immunoassay from F. Hoffmann-La Roche Ltd (Roche).
The EC approval of REKOVELLE is based on a comprehensive clinical data package, including results from the Phase 3 ESTHER trials (Evidence-based Stimulation Trial with Human rFSH in Europe and Rest of World).
Results of the ESTHER-1 trial were accepted for publication in Fertility & Sterility (article in press and available early online). The data shows that individualised treatment with REKOVELLE (follitropin delta), as compared to treatment with conventional rFSH (follitropin alfa), had similar results for the co-primary endpoints of ongoing pregnancy rates and ongoing implantation rates.
Patients receiving REKOVELLE also reached the optimum oocyte yield (8–14 oocytes) more often than those receiving conventional rFSH treatment, with fewer clinically-relevant instances of poor and excessive ovarian response. In addition, ovarian hyperstimulation syndrome (OHSS) and/or OHSS preventive interventions occurred less frequently (p<0.05) in women receiving REKOVELLE than women receiving conventional rFSH treatment.
ESTHER trials principal investigator Professor Anders Nyboe Andersen said: “REKOVELLE’s individualised dosing regimen offers physicians a new method to deliver a consistent, evidence-based approach to personalising treatment for their patients, based on AMH, a highly predictive biomarker.
“Using validated protocols for individualisation could help physicians facilitate the best possible outcomes for their patients by ensuring efficacy is maintained while also reducing complications during treatment.”
REKOVELLE is an integral part of Ferring’s commitment to translating the practice of personalised medicine into reproductive health and fertility.
Ferring Pharmaceuticals executive board president and COO 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.”
About REKOVELLE (follitropin delta)
Follitropin delta (also known as FE 999049) is the first recombinant follicle stimulating hormone (rFSH) derived from a human cell line (PER.C6 cell line).
It has been developed for individualised dosing based on a woman’s serum anti-Müllerian hormone (AMH) level, as determined by a companion diagnostic, the Elecsys AMH Plus immunoassay from Roche and her body weight. Follitropin delta is structurally and biochemically distinct from other existing recombinant FSH treatments.
About the ESTHER trials
The ESTHER trials (Evidence-based Stimulation Trial with Human rFSH in Europe and Rest of World) were randomised, assessor-blind, controlled, multicentre Phase 3 trials involving patients in 11 countries, and over 2,000 cycles of controlled ovarian stimulation.