New indication application for Myovant/Pfizer Myfembree is accepted by the US FDA

Pfizer and Myovant Sciences recently announced that the US Food and Drug Administration (FDA) has accepted Myfembree (relugolix 40mg, estradiol 1.

In December 2020, Pfizer and Myovant reached a US$4.

According to the terms of the cooperation, Myovant and Pfizer are jointly commercializing Myfembree in the United States

The application for new indications for EMS-related moderate to severe pain is based on the support of SPIRIT project data

Endometriosis (EMS) is an estrogen-dependent inflammatory disease in which tissues similar to the endometrium are found outside the uterine cavity, usually in the lower abdomen or pelvis, ovaries, Bladder and colon

Symptoms associated with EMS include chronic pelvic pain, painful ovulation, pain during or after intercourse, severe bleeding, fatigue, and infertility

For EMS-related pain, according to current guidelines, the initial treatment plan includes hormonal contraceptives and over-the-counter analgesics

It is worth mentioning that AbbVie's compound product Oriahnn (elagolix, estradiol, norethindrone acetate capsules) is the first non-surgical, oral option for the treatment of uterine fibroids-related menorrhagia (HMB) in premenopausal women.

In July 2018, elagolix (trade name: Orilissa) was approved by the US FDA for the treatment of moderate to severe pain associated with endometriosis (EMs)

Relugolix chemical structure and mechanism of action (source of structural formula: medchemexpress.

Relugolix is ​​an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, which can reduce the production of ovarian estradiol by blocking GnRH receptors in the pituitary gland.

relugolix is ​​developed for 4 therapeutic indications: (1) treatment of female uterine fibroids; (2) treatment of female endometriosis; (2) treatment of male prostate cancer; (4) female contraception

relugolix was developed by Takeda, and Myovant Sciences (a company formed by Roivant and Takeda) obtained the exclusive worldwide license in June 2016 except for Japan and other Asian countries

Prostate cancer/Uterine fibroids/endometriosis (pictures from: istockphoto.

Myfembree (relugolix 40mg, estradiol 1.

It is worth mentioning that Orgovyx is the first and only oral GnRH receptor antagonist approved by the US FDA for the treatment of advanced prostate cancer

Myovant and Pfizer submitted a new indication application for Myfembree to the US FDA in the first half of 2021 for the treatment of moderate to severe pain related to female endometriosis (EMS)
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In addition, based on the 100% inhibition rate of relugolix compound tablets on female ovulation in the phase 1 study, Myovant and Pfizer launched a phase 3 clinical trial in April this year to evaluate the contraceptive effect of relugolix compound tablets in high-risk female populations
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Original source: Myovant Sciences and Pfizer Announce FDA Acceptance of Supplemental New Drug Application for MYFEMBREE for the Management of Moderate to Severe Pain Associated With Endometriosis