Richter gets positive CHMP opinion for uterine fibroid drug
Hungarian pharmaceutical company Gedeon Richter on Friday said the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of its drug RYEQO for treatment of uterine fibroid symptoms.
The European Commission will review the CHMP recommendation and a final decision on the marketing authorisation application is expected in about two months, clearing the way for sales of RYEQO in all states of the European Economic Area.
RYEQO contains 40mg relugolix, which reduces the amount of estrogen and other hormones produced by the ovaries, 1.0mg estradiol, which may reduce the risk of bone loss, and 0.5mg norethisterone acetate, a progestin that is necessary when women with a uterus take estrogen.
