FDA Drug Approvals, Obstetrics and Gynecology — 2021 Midyear Review

August 20, 2021

Brexafemme (ibrexafungerp)

Ibrexafungerp is an oral triterpenoid antifungal agent indicated for vulvovaginal candidiasis (VVC) in adult and postmenarchal women. Ibrexafungerp inhibits glucan synthase, an enzyme involved in the formation of 1,3-beta-D-glucan, an essential component of the fungal cell wall. It is the first drug approved in a new antifungal class for VVC in more than 20 years. Additionally, it is the first nonazole antifungal for vaginal yeast infections.

Approval was supported by 2 randomized, placebo-controlled trials that included over 500 participants. Efficacy was assessed by clinical outcome and a test-of-cure at a follow-up visit. Results showed statistically significant results for a complete clinical response and negative culture. Brexafemme prescribing information

Nextstellis (estetrol/drospirenone)

Estetrol/drospirenone is indicated for use by females of reproductive potential to prevent pregnancy. The combination is the first to contain estetrol (E4), a synthetic analogue of native estrogen that is present during pregnancy. It is selective for nuclear estrogen receptor (ER)–alpha and ER-beta. Treatment results in a decrease of follicle-stimulating hormone and luteinizing hormone, ultimately leading to ovulation suppression.

Other obstetrics & gynecology approval

Myfembree (relugolix/estradiol/norethindrone acetate) - New combination approved for management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. It is a fixed-dose combination tablet containing relugolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist. Relugolix binds to and blocks GnRH receptors in the anterior pituitary gland. Blocking GnRH receptors decreases the release of gonadotropins (ie, luteinizing hormone, follicle-stimulating hormone), thereby decreasing the downstream production of estrogen and progesterone by the ovaries in women. It also contains estradiol, which reduces the increased bone resorption and resultant bone loss that can occur because of lower circulating estrogen concentrations from relugolix alone. Norethindrone protects the uterus from potential adverse endometrial effects of unopposed estrogen.

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