EMA Upholds Marketing Authorization for Ferring's Infertility Treatment, Rekovelle (Follitropin Delta)
EMA Confirms Continued Regulatory Approval
The European Medicines Agency (EMA) has officially confirmed the maintenance of the marketing authorization for Rekovelle (follitropin delta), an infertility treatment developed by Swiss-based Ferring Pharmaceuticals. This decision follows the EMA's review of the Periodic Safety Update Report (PSUR), a routine assessment conducted to ensure the ongoing safety and efficacy of the product. Since its initial approval in the European Union (EU) in December 2016, Rekovelle has consistently demonstrated a favorable safety profile, as acknowledged by the regulatory authority. This confirmation effectively manages regulatory risks, supports the continuity of the product supply chain, and reinforces its market position.
First rFSH Derived from Human Cell Line
Rekovelle represents a pioneering advancement in infertility treatment, being the first recombinant follicle-stimulating hormone (rFSH) derived from a human cell line (PER.C6) using recombinant DNA technology. Unlike conventional rFSH products produced using Chinese Hamster Ovary (CHO) cells, Rekovelle exhibits a glycosylation pattern more closely resembling that of naturally produced FSH. This results in a longer half-life and more consistent biological activity, allowing for more precise prediction of ovarian response in patients. This technological distinction is a key factor in sustaining Ferring's competitive advantage in the global biopharmaceutical market.
Personalized Precision Medicine with Enhanced Convenience
A key strength of Rekovelle lies in its individualized dosing approach, which utilizes a combination of anti-Müllerian hormone (AMH) levels and body weight to determine the optimal dosage for each patient. Traditional treatments often rely on standardized dosages, which can lead to either overstimulation or insufficient response. The Phase 3 ESTHER-1 study demonstrated that Rekovelle achieved an ongoing pregnancy rate of 30.7%, demonstrating non-inferiority compared to Gonal-F (Merck KGaA), while also exhibiting a superior safety profile. This personalized approach reduces the frequency of early interventions required by healthcare professionals to prevent ovarian hyperstimulation syndrome (OHSS), a serious complication, and significantly improves treatment success rates.
Navigating Intensifying Competition in the Global Infertility Market
The global recombinant FSH (rFSH) market is currently valued at approximately $1.17 billion and is projected to grow at a compound annual growth rate of 5.6% through 2035, representing a high-value market. Rekovelle faces increasing competition from biosimilar products such as Puregon, Ovaleap, and Bemfola, marketed by Organon. In this competitive landscape, the EMA's continued approval is crucial not only for maintaining market share but also for facilitating expansion into emerging markets with high growth potential, such as the Asia-Pacific region. Ferring Pharmaceuticals is continuously strengthening its premium brand image through the accumulation of real-world evidence (RWE) and the widespread adoption of its multi-dose pen device.
The EMA's continued approval of Rekovelle provides a solid short-term foundation for Ferring to solidify its position in the global recombinant FSH market, which is expected to reach approximately $1.17 billion in 2025. The data from the Phase 3 ESTHER-1 study, which demonstrated non-inferiority to Gonal-F with an ongoing pregnancy rate of 30.7% and a significant reduction in the rate of OHSS treatment interventions, is a key asset that enhances physician confidence in prescribing the drug. In the medium to long term, the personalized companion diagnostic model (Elecsys AMH Plus) is expected to be a key mechanism for defending the premium pricing of the original drug in the face of aggressive competition from low-cost biosimilars such as Ovaleap and Bemfola. With the rapid expansion of infertility treatment infrastructure in global markets such as the Asia-Pacific region, maintaining regulatory integrity and expanding market penetration are crucial.
Source: EMA (ema)