RYEQO (relugolix/estradiol/norethisterone acetate) - Endometriosis

The Committee deems that the clinical benefit of RYEQO (relugolix/estradiol/norethisterone acetate) is substantial in the MA indication.

Considering:

• the demonstrated superiority of RYEQO (relugolix/estradiol/norethisterone acetate) versus placebo on the two co-primary endpoints (dysmenorrhea and non-menstrual pelvic pain) in two phase 3 clinical studies with a comparable methodology, despite the fact that clinically relevant comparators exist and a comparison would have been possible,
• the analgesic efficacy versus placebo, which appears to be more marked on dysmenorrhoea than on non-menstrual pelvic pain, with a non-negligible placebo effect, assessed on the basis of scores for which the thresholds set are debatable, and opioid consumption that reduces significantly but is not eliminated with the use of RYEQO (relugolix/estradiol/norethisterone
  acetate),
• the safety profile of RYEQO (relugolix/estradiol/norethisterone acetate), which appears to be favourable; however, the maximum follow-up of 104 weeks of treatment only concerns a population of 163 patients, making it impossible to guarantee the absence of an effect on bone mineral density with longer-term use. As a precaution, women with a history of a low trauma fracture or other risk factors for osteoporosis or bone loss could not be included in the studies,
• the occurrence of pregnancies during the studies calls into question the contraceptive efficacy of RYEQO (relugolix/estradiol/norethisterone acetate); these pregnancies possibly being related to omission of doses in the majority of the women concerned in the month prior to the estimated conception date,

the Transparency Committee considers that RYEQO (relugolix / estradiol / norethisterone acetate) provides no clinical added value (CAV V) in the care pathway for the symptomatic treatment of endometriosis in adult women of reproductive age with a history of previous medical or surgical treatment for their endometriosis.