Saint-Prex, Switzerland, 30 October 2015 – Ferring Pharmaceuticals announced today that the filing for the Marketing Authorisation Application for REKOVELLE® (follitropin delta) has been accepted for review by the European Medicines Agency (EMA). REKOVELLE is a novel human recombinant follicle-stimulating hormone (rhFSH) intended for controlled ovarian stimulation (COS) in women undergoing assisted reproductive technology (ART) therapy such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI).1-3 The submission is supported by comprehensive data from the Phase 3 ESTHER trials (Evidence-based Stimulation Trial with Human rFSH in Europe and Rest of World) involving 1,326 patients from 37 fertility clinics in 11 countries.2,3
If approved, REKOVELLE would be administered in an individualised dosing regimen according to both the measurement of the woman’s serum anti-Müllerian hormone (AMH), a biomarker that assesses ovarian reserve and predicts ovarian response to stimulation, as well as her body weight. Fertility specialists would assess each patient’s biomarker profile and characteristics, and prescribe a precise fixed daily dose of REKOVELLE from the start of stimulation. This approach of controlled ovarian stimulation with an individualised REKOVELLE dosing regimen was prospectively studied in the ESTHER-1 trial.2 If approved, REKOVELLE would be paired with the recently launched fully-automated Elecsys® AMH immunoassay from Roche4.
Personalised treatment is a new approach to the management of fertility treatment, with the ultimate goal of helping couples to conceive in an efficient and safe manner.1,5,6,7,8
“Ferring Pharmaceuticals has a long heritage in reproductive health and the acceptance of the Marketing Authorisation Application filing for REKOVELLE in controlled ovarian stimulation represents our commitment to innovation and advancing the role of personalised medicine in the area of fertility,” commented Per Falk, MD, PhD, Executive Vice President and Chief Scientific Officer, Ferring.
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About REKOVELLE (follitropin delta)
REKOVELLE (also known as FE 999049) is the first human recombinant follicle stimulating hormone derived from a human cell line that has been developed for individualised dosing using a companion anti-Müllerian hormone (AMH) diagnostic immunoassay.2 REKOVELLE is a New Molecular Entity (NME) which is clinically distinct1,9 from other follitropins and is not a biosimilar.
About Ferring Pharmaceuticals
Headquartered in Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. To learn more about Ferring or its products please visit www.ferring.com.
About the Elecsys® AMH immunoassay from Roche
The Elecsys® AMH immunoassay from Roche has been shown to provide a precise, reliable and robust measurement of AMH levels.10-15 The fully automated Elecsys® AMH immunoassay determines AMH levels in 18 minutes, making it appropriate for routine clinical use and providing clinical confidence in the reliable assessment of ovarian reserve.10-15
For more information
Tel. +41 (0) 58 301 00 53
Tel. +41 (0) 58 301 00 51
REKOVELLE is a trade mark of Ferring B.V., registered in the European Union and under examination elsewhere.
ELECSYS® is a trademark of Roche. All other trademarks are the property of their respective owners.
1. Arce J-C, Nyboe Andersen A, Fernandez Sanchez M, et al. Ovarian response to recombinant human follicle-stimulating hormone: a randomized, antimullerian hormone–stratified, dose–response trial in women undergoing in vitro fertilization/intracytoplasmic sperm injection Fertil Steril. 2014 Dec;102(6):1633-40.
2. ESTHER-1 trial. www.clintrials.gov Available at: https://clinicaltrials.gov/ct2/show/NCT01956110. Last accessed: October 2015.
3. ESTHER-2 trial. www.clintrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT01956123. Last accessed: October 2015.
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9. Olsson H, Sandström R, Grundemar L. Different pharmacokinetic and pharmacodynamic properties of recombinant follicle-stimulating hormone (rFSH) derived from a human cell line compared with rFSH from a non-human cell line. J Clin Pharmacol 2014;54(11):1299-307.
10. Roche Diagnostics. Elecsys® AMH (anti-Mullerian hormone): Method sheet. 2015. https://pim-eservices.roche.com. Last accessed 07 October 2015.
11. Gassner D, Jung R. First fully automated immunoassay for anti-Müllerian hormone. Clin Chem Lab Med. 2014;52(8):1143-52.
12. Anderson RA, Anckaert E, Bosch E, et al. Prospective study into the value of the automated Elecsys antimüllerian hormone assay for the assessment of the ovarian growing follicle pool. Fertil Steril. 2015;103(4):1074–80.e4.
13. Deeks, ED. Elecsys® AMH Assay: a review in anti-Müllerian hormone quantification and assessment of ovarian reserve. Mol Diagn Ther 2015; 19:245-249.
14. Nelson SM, Pastuszek E, Kloss G, et al. Two new automated, compared with two enzyme-linked immunosorbent antimüllerian hormone assays. Fertil Steril. 2015 Oct;104(4):1016-1021.e6.
15. Hyldgaard J, Bor P, Ingerslev HJ, et al. Comparison of two different methods for measuring anti-mullerian hormone in a clinical series. Reprod Biol Endocrinol. 2015 Sep 22;13(1):107.