- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
- Events & Workshops
Ferring receives positive CHMP opinion for IVF aid Rekovelle
19 October 2016 • Author: Niamh Louise Marriott, Digital Content Producer
The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Ferring Pharmaceuticals’ Rekovelle (follitropin delta), recommending that the European Commission grants marketing authorisation for use in controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART), such as an in vitrofertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
Following a European Commission decision, authorisation can also be granted by national authorities in Norway and Iceland.
If approved, Rekovelle would be administered using an individualised dosing regimen according to a woman’s serum anti-Müllerian hormone (AMH) level and her body weight.
AMH is a biomarker used to assess ovarian reserve. This can help to predict ovarian response to controlled ovarian stimulation and thus identify patients who may be at higher risk of experiencing reduced efficacy or increased safety concerns.
The individualised dosing regimen determines a specific daily dose of Rekovelle for each patient, with the aim of maintaining efficacy and improving safety during controlled ovarian stimulation.
“The individualised dosing regimen for Rekovelle aims to further enrich the personalised care that fertility specialists offer their patients,” said Dr Per Falk, MD PhD CSO and Executive VP at Ferring. “If approved, this would be the first pairing of a drug with a companion diagnostic for individualised dosing in reproductive medicine.”
The CHMP positive opinion is based on a comprehensive clinical development programme, including the Phase 3 ESTHER trials (Evidence-based Stimulation Trial with Human recombinant FSH in Europe and Rest of World), involving 1,326 patients in 11 countries, and over 2,000 cycles of controlled ovarian stimulation.
Non-inferiority was demonstrated in a Phase 3 trial for the co-primary endpoints of ongoing pregnancy rate and ongoing implantation rate for Rekovelle compared to follitropin alfa (conventional treatment and dosing regimen). Secondary endpoints, including the number of oocytes retrieved and number of blastocysts obtained, were comparable between both groups. The Phase 3 clinical trials also demonstrated no increased immunogenicity risk and a good safety profile for Rekovelle with repeated cycles of controlled ovarian stimulation.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) EUROGENTEC F.P.S. Food and Pharma Systems Srl IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics