Follitropin Delta (Rekovelle®): A Comprehensive Pharmacological and Clinical Review of a Novel Recombinant Gonadotropin with an Individualized Dosing Algorithm

I. Executive Summary

Follitropin delta, marketed under the brand name Rekovelle®, represents a significant advancement in the field of reproductive medicine, specifically in the domain of controlled ovarian stimulation (COS) for women undergoing Assisted Reproductive Technologies (ART).[1] Developed by Ferring Pharmaceuticals, it is a recombinant human follicle-stimulating hormone (rFSH) distinguished by two pioneering characteristics: its production in a human-derived cell line and its application of a prospective, individualized dosing algorithm based on patient-specific biomarkers.[3] These innovations collectively address the long-standing clinical challenge of balancing the efficacy of ovarian stimulation with the critical need for patient safety.

The core clinical proposition of Follitropin delta is its ability to achieve reproductive outcomes that are non-inferior, and in certain populations statistically superior, to those of conventional follitropins (follitropin alfa and follitropin beta), while concurrently offering a markedly improved safety profile.[3] This is primarily characterized by a clinically and statistically significant reduction in the incidence of Ovarian Hyperstimulation Syndrome (OHSS), the most serious iatrogenic complication of COS.[5]