Ferring EU filing for fertility treatment Rekovelle accepted
Privately-held Swiss firm Ferring Pharmaceuticals said Friday that the Marketing Authorization Application filing for Rekovelle (follitropin delta) has been accepted for review by the European Medicines Agency.
Rekovelle is a novel human recombinant follicle-stimulating hormone (rhFSH) intended for controlled ovarian stimulation (COS) in women undergoing assisted reproductive technology (ART) therapy such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI).The submission is supported by comprehensive data from the Phase III ESTHER trials (Evidence-based Stimulation Trial with Human rFSH in Europe and Rest of World) involving 1,326 patients from 37 fertility clinics in 11 countries.
The company expects to launch the drug in the European markets in the second half of 2016, chief scientific officer Per Falk recently told The Pharma Letter in an exclusive interview (TPL September 23).
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