Date:
August 9, 2021
Issue #:
1630
Summary:
Myfembree (Myovant/Pfizer), an oral fixed-dose
combination of the gonadotropin-releasing hormone
(GnRH) receptor antagonist relugolix, the estrogen
estradiol, and the progestin norethindrone acetate,
has been approved by the FDA for management of
heavy menstrual bleeding associated with uterine
leiomyomas (fibroids) in premenopausal women. It is
the second product to be approved in the US for this
indication; Oriahnn, which contains the GnRH receptor
antagonist elagolix in combination with estradiol and
norethindrone acetate, was approved earlier. Relugolix
was approved for treatment of advanced prostate
cancer as Orgovyx in 2020.
combination of the gonadotropin-releasing hormone
(GnRH) receptor antagonist relugolix, the estrogen
estradiol, and the progestin norethindrone acetate,
has been approved by the FDA for management of
heavy menstrual bleeding associated with uterine
leiomyomas (fibroids) in premenopausal women. It is
the second product to be approved in the US for this
indication; Oriahnn, which contains the GnRH receptor
antagonist elagolix in combination with estradiol and
norethindrone acetate, was approved earlier. Relugolix
was approved for treatment of advanced prostate
cancer as Orgovyx in 2020.
