The European Commission (EC) has approved Gedeon Richter and Sumitomo Pharma’s Type II Variation application for RYEQO for endometriosis.
It is indicated as a symptomatic therapy in endometriosis patients who previously underwent a medical or surgical procedure.
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RYEQO comprises 40mg relugolix, 1mg estradiol and 0.5mg norethisterone acetate.
Relugolix reduces the amount of oestrogen produced by the ovaries; estradiol, an oestrogen, cuts bone loss risk; and norethisterone acetate, a progestin, is vital when women with a uterus receive oestrogen.
The latest development comes after the European Medicines Agency’s Committee for Medicinal Products for Human Use provided a positive opinion in September 2023 on the approval of RYEQO.
With the EC’s approval, the treatment can now be used in all European Union member states.
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By GlobalDataGedeon Richter Women’s Health global head Dr Peter Turek stated: “We are delighted that this approval has opened the way to offer a viable symptomatic treatment option for many women living with endometriosis.
“As we aim to become a leading pharmaceutical company in the field of women’s healthcare, a sustained broadening of the therapeutic reach of our core innovative products is of utmost importance for us.”
In July 2021, RYEQO received approval from the EMA to treat adult women with moderate-to-severe symptoms linked to uterine fibroids.
