Date:
April 5, 2021
Issue #:
1621
Summary:
Oriahnn (Abbvie), a fixed-dose combination of the
gonadotropin-releasing hormone (GnRH) receptor
antagonist elagolix, the estrogen estradiol, and the
progestin norethindrone acetate copackaged with
elagolix alone, has been approved by the FDA for oral
treatment of heavy menstrual bleeding associated
with uterine leiomyomas (fibroids) in premenopausal
women. It is the first product to be approved in the
US for this indication. Elagolix (Orilissa) has been
available since 2018 for treatment of moderate to
severe pain associated with endometriosis. The
GnRH receptor antagonist relugolix (Orgovyx), which is
approved for treatment of advanced prostate cancer,
is being reviewed by the FDA for use in combination
with estradiol and norethindrone acetate for the same
indication as Oriahnn.
gonadotropin-releasing hormone (GnRH) receptor
antagonist elagolix, the estrogen estradiol, and the
progestin norethindrone acetate copackaged with
elagolix alone, has been approved by the FDA for oral
treatment of heavy menstrual bleeding associated
with uterine leiomyomas (fibroids) in premenopausal
women. It is the first product to be approved in the
US for this indication. Elagolix (Orilissa) has been
available since 2018 for treatment of moderate to
severe pain associated with endometriosis. The
GnRH receptor antagonist relugolix (Orgovyx), which is
approved for treatment of advanced prostate cancer,
is being reviewed by the FDA for use in combination
with estradiol and norethindrone acetate for the same
indication as Oriahnn.
