YSELTY (linzagolix) - Uterine fibroids

The Committee deems that the clinical benefit of YSELTY (linzagolix) 100 mg and 200 mg, film-coated tablet, is substantial in the MA indication.

In view of:

• the evidence of superiority versus placebo of both dosages of YSELTY (linzagolix) with or without associated oestroprogestative therapy, on menstrual blood loss volume (defined by a volume ≤ 80 mL and a reduction ≥ 50% in relation to inclusion) (primary endpoint) assessed at 24 weeks in two phase III studies,
• an effect size of linzagolix which appears to be modest on bleeding, with an notable efficacy of the placebo observed in both studies,
• the lack of comparative data versus a clinically relevant comparator, despite such a comparison being feasible, except with RYEQO (relugolix / oestradiol / norethisterone acetate) with an overlapping indication, due to their concomitant development,
• the lack of robust data on any effect of YSELTY (linzagolix) on other fibroid-related symptoms of interest such as pain and reduction in fibroid volume in particular,
• the lack of robust data on any impact of YSELTY (linzagolix) on quality of life, even though this condition has been identified as having an impact on women’s quality of life, sexuality and reproductive health,
• the safety profile YSELTY (linzagolix) which shows a partially attenuated, but not cancelled, effect on mineral bone density by adding oestroprogestative therapy, with treatment follow-up with linzagolix limited to 52 weeks on overweight or obese populations considered as at lower risk of impact on bone density,

the Committee deems that YSELTY 100 mg, 200 mg (linzagolix) film-coated tablet provides no clinical added value (CAV V) in the current therapeutic strategy, which includes the relevant comparators.