Report on Corifollitropin Alfa (DB09066): A Sustained Follicle Stimulant for Reproductive Medicine

Section 1: Executive Summary

Corifollitropin alfa, marketed under the brand name Elonva, is a first-in-class, long-acting follicle-stimulating hormone (FSH) agonist developed through recombinant DNA technology for application in reproductive medicine.[1] As a biotech drug, its primary clinical innovation lies in its unique pharmacokinetic profile, which allows a single subcutaneous injection to initiate and sustain multifollicular growth for the first seven days of a Controlled Ovarian Stimulation (COS) cycle.[3] This offers a significant paradigm shift from conventional recombinant FSH (rFSH) therapies, which necessitate daily injections. The reduction in injection frequency directly addresses a major source of patient burden, stress, and potential for administration errors and non-compliance, which are well-documented challenges in Assisted Reproductive Technology (ART).[3]

The clinical development program for Corifollitropin alfa has produced robust evidence from large-scale, pivotal Phase III trials demonstrating its non-inferiority to daily rFSH regimens in terms of key efficacy endpoints, including ongoing pregnancy and live birth rates.[7] A consistent and statistically significant finding across these studies is a modest increase in the mean number of oocytes retrieved per cycle in patients treated with Corifollitropin alfa compared to daily rFSH.[1] The safety and tolerability profile of Corifollitropin alfa is comparable to that of established daily gonadotropins. The most significant clinical risk is Ovarian Hyperstimulation Syndrome (OHSS), a known class effect of all gonadotropins; however, its incidence with Corifollitropin alfa has been shown to be similar to that observed with standard-of-care daily rFSH protocols.[3]