Myovant Sciences and Pfizer Announce FDA Acceptance of sNDA for MYFEMBREE to Treat Moderate to Severe Endometriosis-Associated Pain

September 11, 2021 /BioValleyBIOON/ --Pfizer(Pfizer) and Myovant Sciences recently jointly announced that the U.S. Food and Drug Administration (FDA) has acceptedSupplemental New Drug Application (sNDA) for Myfembree (relugolix 40 mg, estradiol 1.0 mg, norethindrone acetate 0.5 mg) for the treatment of moderate to severe pain associated with endometriosis (EMS).FDAThe Prescription Drug User Fee Act (PDUFA) target date for this sNDA has been designated as May 6, 2022.Myfembree is a combination tablet, among its active pharmaceutical ingredients: relugolix is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces the levels of estrogen (and other hormones) produced by the ovaries; estradiol (an estrogen) reduces the risk of bone loss; norethindrone acetate (a progestin) is necessary for women with a uterus who are taking estrogen.

In December 2020, Pfizer and Myovant entered into a $4.2 billion agreement to jointly developOral GnRH receptor antagonist relugolix. May 2021,Myfembree Receives U.S.FDAApproved, becoming the first once-daily medication for the treatment of heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women, for a treatment duration of up to 24 monthsThe approval is based on data from the Phase 3 LIBERTY program.

Under the terms of the collaboration, Myovant and Pfizer are jointly commercializing Myfembree in the United States. Uterine fibroids are a chronic, debilitating condition, with the two most common symptoms being heavy menstrual bleeding (HMB) and pain. In the United States, uterine fibroids affect millions of women, resulting in over 250,000 hysterectomies annually. The launch of Myfembree provides women with uterine fibroids a convenient, once-daily oral, non-invasive treatment that offers clinically meaningful relief from heavy menstrual bleeding.

This new indication application for moderate to severe pain associated with endometriosis (EMS) is supported by data from the SPIRIT program. The program comprises two multinational, replicate pivotal clinical studies (SPIRIT 1 and SPIRIT 2) and one open-label extension study. SPIRIT 1 and SPIRIT 2 evaluated more than 1,200 women with EMS-associated pain over a 24-week period. The open-label extension study provided open-label Myfembree treatment to eligible women who completed SPIRIT 1 and SPIRIT 2, to evaluate the safety and sustained efficacy of long-term therapy.

Dr. Juan Camilo Arjona Ferreira, Chief Medical Officer of Myovant Sciences, stated: “Women with endometriosis often experience debilitating symptoms that impact their daily lives—unfortunately, many do not find relief with currently available treatment options. If this indication is approved, we believe Myfembree has the potential to redefine care for women with endometriosis as an effective, single-pill, once-daily treatment option.”

James Rusnak, M.D., Senior Vice President, Global Product Development and Chief Development Officer, Medicine and Hospitals, Pfizer, said: “The sNDA submitted for Myfembree for the treatment of endometriosis-associated pain reflects our commitment to addressing areas of significant unmet medical need in women’s health. We look forward to bringing this important new treatment option to women with endometriosis.”

Endometriosis (endometriosis, EMS) is an estrogen-dependent inflammatory disease in which endometrium-like tissue is found outside the uterine cavity, typically located in the lower abdomen or pelvis, ovaries, bladder, and colon. This extrauterine endometrium-like tissue causes chronic inflammation and can lead to scarring and adhesions.

Symptoms associated with EMS include chronic pelvic pain, ovulatory pain, pain during or after intercourse, heavy bleeding, fatigue, and infertility. EMS also affects overall physical, psychological, and social well-being, necessitating a multidisciplinary care approach.

For EMS-related pain, current guidelines recommend initial treatment regimens comprising hormonal contraceptives and over-the-counter analgesics. In more severe cases, LHRH agonists such as leuprolide acetate are utilized for short-term therapy. It is estimated that 6 million women in the United States experience EMS symptoms, with approximately 1 million demonstrating an inadequate response to current pharmacological treatments, necessitating further therapy. Globally, approximately 200 million women are affected by EMS.

Notably, AbbVie's combination productOriahnn (elagolix, estradiol, and norethindrone acetate capsules)is the first non-surgical, oral option for the treatment of heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women. The drug received U.S. approval in May 2020.FDAApproved. Regarding administration, Oriahnn is administered orally twice daily. Among the active pharmaceutical ingredients of this drug,Elagolix is also an oral GnRH receptor antagonist.

In July 2018, elagolix (brand name: Orilissa) was approved by the U.S. FDA for the treatment of moderate to severe pain associated with endometriosis (EMs). This approval made OrilissaThe first oral GnRH receptor antagonist approved specifically for the treatment of moderate to severe endometriosis-associated pain, and is also the first in over a decadeFDAThe first approved oral medication for the treatment of moderate to severe pain associated with endometriosis.

Relugolix Chemical Structure and Mechanism of Action (Source of chemical structure image: medchemexpress.com)

Relugolix was developed by Takeda. Myovant Sciences (a company established by Roivant and Takeda) obtained exclusive global licensing rights in June 2016, excluding Japan and other Asian countries. In Japan, relugolix was approved in January 2019 and marketed under the brand name Relumina for the improvement of the following symptoms caused by uterine fibroids: heavy menstrual bleeding, lower abdominal pain, low back pain, andAnemia。

Prostate Cancer/Uterine Fibroids/Endometriosis (Images sourced respectively from: istockphoto.com, clinicaladvisor.com, insider.com)

Myfembree (relugolix 40 mg, estradiol 1.0 mg, norethindrone acetate 0.5 mg) marks Myovant's second U.S. FDA-approved product in its relugolix development program. On December 18, 2020,Orgovyx (relugolix, 120 mg tablets)ObtainFDAApproved for the treatment of adult patients with advanced prostate cancer.

It is worth noting that,Orgovyx is from the United States.FDAThe First and Only Oral GnRH Receptor Antagonist Approved for the Treatment of Advanced Prostate Cancer. The drug was approved through the priority review program. In the Phase 3 HERO trial, the response rate with relugolix treatment reached 96.7%, significantly superior to leuprolide acetate (88.8%), while reducing the risk of major adverse cardiovascular events (MACE) by 54%.

Myovant and Pfizer in the first half of 2021 to the United StatesFDASubmitted a new indication application for Myfembree for the treatment of moderate to severe pain associated with endometriosis (EMS) in women. Additionally, based on the Phase 1 study100% Inhibition Rate of Female Ovulation by Relugolix Combination Tablets, Myovant and Pfizer initiated a Phase 3 trial in April this yearClinical Trial, evaluate the contraceptive efficacy of relugolix combination tablets in high-risk female populations. (Bioon.com)

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