LIBERTY randomised withdrawal study suggests potential long-term benefit of combination therapy with relugolix plus estradiol plus norethindrone acetate in women with uterine fibroids who had competed LIBERTY long-term extension study

Study in women randomised at week 52 to once weekly relugolix combination therapy(ReCT) or placebo for 1-year met primary endpoint, with 78.4% who continued on ReCT achieving sustained responder rate (menstrual blood loss <80mL) vs 15.1% who discontinued treatment through week 76

SPS commentary:

The FDA is currently reviewing combination therapy with relugolix, a GnRH antagonist, for the treatment of women with uterine fibroids, with a decision expected by 1 June 2021.

A marketing application was submitted last year to the European Medicines Agency for relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of women with moderate to severe symptoms associated with uterine fibroids.

PharmaTimes