EU approves recombinant fertility drug duo
the rising number of women experiencing fertility problems,
has now been approved for use in the Europe.
The approval decision applies to all 27 European member states, along with Iceland, Liechtenstein and Norway, and will be available as of this year's third quarter. Drug giant Merck Serono's new treatment is intended to stimulate egg production in the ovaries of women who are experiencing infertility due to severe luteinising hormone (LH) and follicle stimulating hormone (FSH) deficiency. "Women who have a severe deficiency in both LH and FSH represent less than two per cent of the total number of women with infertility problems and so we expect the volume of sales for this treatment to be limited, although it is company policy not to reveal sales forecasts," a Merck spokesperson told BioPharma-Reporter.com. The biologic drug, called Pergoveris, is unique in that it is the first to combine recombinant human follicle stimulating hormone (FSH) (r-hFSH or follitropin alfa 150IU) and recombinant human luteinising hormone (LH) (r-hLH or lutropin alfa 75IU) in the same dosage form, delivered by subcutaneous injection, according to the firm. It is derived from a Chinese hamster ovary (CHO) cell line. The advantage of having a combination treatment is that "it is much easier for the women receiving it," said the spokesperson. Without a combination treatment, two separate injections, one of LH and one of FSH, would have to be administered once a day, for up to three weeks. "The advantage of a recombinant product is that it provides a more consistent and pure product," the spokesperson said. "This means that when you inject a recombinant product, you are always injecting the same quantity and quality of active product each time," she said. A non-recombinant LH and FSH combination treatment is currently on the market, made by Ferring, although this is derived from the urine of postmenopausal women. "Because it is not a recombinant product it is less consistent than Pergoveris," the spokesperson said. Around one in seven couples have trouble conceiving naturally, although predictions have been made by leading fertility experts that the infertility rate is set to double in Europe over the next decade, particularly as couples are waiting until much later on in life to 'begin trying' than ever before. Female infertility accounts for about 40 per cent all infertility cases, and arises for a variety of reasons, most of which are hormone-related, such as premature ovarian failure, polycystic ovarian syndrome (PCOS), advanced age, and irregular menstruation such as amenorrhea. Germany-based Merck, which prides itself on having a large portfolio of fertility treatments, with which it "helps to build families," said it is "not pursuing a filing for the drug in the US market," although the spokesperson would not disclose why.
