EU regulators approve Ferring’s rFSH treatment Rekovelle
Ferring’s Rekovelle has been approved by European regulators for controlled ovarian stimulation in women undergoing assisted reproductive technologies.
The firm says Rekovelle is the first recombinant follicle stimulating hormone (rFSH) to be derived from a human cell line and is the first rFSH treatment to be administered with an individualised dosing regimen, based on a woman’s serum anti-Müllerian hormone (AMH) level (a biomarker for assessing ovarian reserve) and her body weight.
Clearance of the treatment came after data from the Phase III ESTHER trials showed that individualised treatment with Rekovelle, 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 taking Ferring’s therapy also reached the optimum oocyte yield more often than those receiving conventional rFSH treatment, with fewer clinically-relevant instances of poor and excessive ovarian response, while ovarian hyperstimulation syndrome (OHSS) and/or OHSS preventive interventions occurred less frequently, the firm noted.
“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,” commented Professor Anders Nyboe Andersen, principal investigator of the ESTHER trials.
“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.”