Privately-held Swiss drugmaker Ferring Pharmaceuticals has received approval from its home regulator to market Rekovelle (follitropin delta), a human recombinant follicle stimulating hormone.
Swissmedic has approved Rekovelle for use in controlled stimulation for induction of the development of multiple follicles in women undergoing assisted reproductive technologies, such as an in vitro fertilization or intracytoplasmic sperm injection.
Rekovelle is a first in that it uses an approved individualized dosing regimen, based on a woman’s anti-Müllerian hormone level and body weight.
The Swissmedic approval comes almost a year after the nod was given by the European Commission, but for Ferring this is a highly important moment, says Michel Pettigrew, president of the company’s executive board and chief executive.
He said: “With Ferring’s headquarters in Switzerland, we are particularly proud to announce the Swissmedic approval of Rekovelle, the first fertility medication to offer women a personalized approach, right from the start of treatment.
“The addition of Rekovelle to Ferring’s reproductive health portfolio reflects our ongoing commitment to addressing unmet patient needs at each stage of the fertility journey, from conception to birth.”
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