Swiss biopharmaceutical company Ferring Pharmaceuticals has reported a positive outcome from the Phase III ESTHER-1 and ESTHER-2 clinical trials of its fertility drug, Rekovelle.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Rekovelle is a recombinant follicle-stimulating hormone (rFSH) extracted from a human cell line and is currently being developed to deliver individualised doses based on the body weight and serum AMH level of a patient.
The results indicated cumulative live birth rates similar to standard follitropin alfa treatment and a favourable safety profile in women with high levels of anti-Müllerian hormone (AMH).
The randomised, assessor-blind, controlled ESTHER-1 trial evaluated a fixed daily dose of Rekovelle in 1,326 patients across 11 countries, while the assessor-blind, controlled ESTHER-2 trial assessed the drug candidate’s immunogenicity in a subset of ESTHER-1 patients who were undergoing repeated cycles of controlled ovarian stimulation for ART.
Ferring Pharmaceuticals executive vice-president and chief scientific officer Per Falk said: “Rekovelle’s individualised dosing regimen, based on a patient’s AMH level and body weight, provides clinicians with a consistent, evidence-based approach to personalising treatment for their patients.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalData“These new Rekovelle analyses add further evidence for a personalised approach to fertility treatment for patients.”
The data from both trials demonstrated a cumulative live birth rate of 43.9% with Rekovelle for fresh embryo transfers following three treatment cycles in subjects undergoing in-vitro fertilisation (IVF), while the rate with follitropin alfa was found to be 44.5%.
Additional analysis indicated a 45.1% ongoing pregnancy rate with Rekovelle and a rate of 45.7% with follitropin alfa.
Image: Ferring Pharmaceuticals headquarters in Switzerland. Photo: courtesy of Ferring International Center.
