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news.The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Ferring Pharmaceuticals’ Rekovelle (follitropin delta) for controlled ovarian stimulation in women undergoing assisted reproductive technologies.
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Follitropin delta is the first recombinant follicle stimulating hormone (FSH) derived from a human cell line.
It has been developed for individualized dosing depending on a woman’s serum anti-Müllerian hormone (AMH) level, as determined by a companion diagnostic, the Elecsys AMH Plus immunoassay from Roche and her body weight.
The CHMP’s positive opinion follows a review of data from the phase 3 Evidence-based Stimulation Trial with Human rFSH in Europe and Rest of World trials that involved 1,326 patients in 11 countries.
Ferring said non-inferiority was showed 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).
The number of oocytes retrieved and number of blastocysts obtained were comparable between the two groups.
The phase 3 trials also demonstrated no increased immunogenicity risk and a better safety profile for Rekovelle with repeated cycles of controlled ovarian stimulation.
Ferring Pharmaceuticals chief scientific officer and executive vice president 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.”