EU approval for Rekovelle

The European Commission has granted marketing authorization for Rekovelle (follitropin delta), a human recombinant follicle stimulating hormone (human rFSH), following a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October.

Privately-held Swiss firm Ferring Pharmaceuticals, the drug’s maker, says the approval is for the use of Rekovelle in controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART), such as an in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycle.

Rekovelle is the first rFSH to be derived from a human cell line and is the first rFSH treatment to be administered with an individualised dosing regimen. Rekovelle’s individualized dosing regimen is based on a woman’s serum anti-Müllerian hormone (AMH) level and her body weight.