Swiss-based Ferring Pharmaceuticals has announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for REKOVELLE (follitropin delta).
The European Commission will grant marketing authorisation for REKOVELLE to use in controlled ovarian stimulation for the development of multiple follicles in women who are undergoing assisted reproductive technologies (ART), such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
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Later on national authorities in Norway and Iceland will authorise REKOVELLE.
Upon securing approval, an individualised dosing regimen will be used to administer REKOVELLE according to a woman’s serum anti-Müllerian hormone (AMH) level and her body weight.
AMH is a biomarker used to assess ovarian reserve, which can help to predict ovarian response to controlled ovarian stimulation.
It will also identify patients who may be at higher risk of experiencing reduced efficacy or increased safety concerns.
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By GlobalDataFerring Pharmaceuticals chief scientific officer and executive vice-president Dr Per Falk said: “The individualised dosing regimen for REKOVELLE aims to further enrich the personalised care that fertility specialists offer their patients.
“If approved, this would be the first pairing of a drug with a companion diagnostic for individualised dosing in reproductive medicine.”
The positive opinion by CHMP is based on a clinical development programme, including the Phase III Evidence-based Stimulation Trial with Human recombinant FSH in Europe and Rest of World (ESTHER) trials that involved 1,326 patients in 11 countries, and more than 2,000 cycles of controlled ovarian stimulation.
The Phase III clinical trials also demonstrated no increased immunogenicity risk and a good safety profile for REKOVELLE.
