Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) announced
today that the U.S. Food and Drug Administration (FDA) has extended
the review period for the supplemental New Drug Application (sNDA)
for MYFEMBREE® (relugolix 40 mg, estradiol 1 mg, and norethindrone
acetate 0.5 mg) for the management of moderate to severe pain
associated with endometriosis. The FDA requires extended time to
review additional information the Agency requested from the
companies regarding bone mineral density. The extended Prescription
Drug User Fee Act (PDUFA) goal date is August 6, 2022.
“We remain confident in the clinical profile of MYFEMBREE and
its potential to become a therapeutic option for the management of
endometriosis-associated pain,” said Juan Camilo Arjona Ferreira,
Chief Medical Officer of Myovant Sciences, Inc. “We will continue
to work closely with the FDA to support the ongoing review of the
sNDA.”
MYFEMBREE® was approved in the U.S. in 2021 for the management
of heavy menstrual bleeding associated with uterine fibroids in
premenopausal women with a treatment duration of up to 24
months.
About Endometriosis Endometriosis is a
condition in which tissue similar to the uterine lining is found
outside of the uterine cavity, which often causes disruptive
symptoms like painful periods, fatigue, pain in the lower back and
abdomen, heavy menstrual bleeding, and even painful or difficult
sexual intercourse. For endometriosis-associated pain, current
treatment options include prescription and over-the-counter pain
medications, oral contraceptives, GnRH agonists, and antagonists.
There are also surgical options including adhesiolysis, cyst
removal, and hysterectomy.
Endometriosis can also impact general physical, mental, and
social well-being, requiring a multi-disciplinary approach to care.
Almost 200 million women suffer from symptoms of endometriosis
globally.i In the U.S., there are approximately 7.5 million
premenopausal women with endometriosis.ii,iii,iv It can take
between four and eleven years to get an endometriosis
diagnosisv,vi,vii,viii and for some women, current treatment
options do not provide relief.ix
About MYFEMBREE®MYFEMBREE
(relugolix, estradiol, and norethindrone acetate) is the first
once-daily oral treatment for heavy menstrual bleeding associated
with uterine fibroids in premenopausal women approved by
the U.S. Food and Drug Administration, with a treatment
duration of up to 24 months. MYFEMBREE contains relugolix, which
reduces the amount of estrogen (and other hormones) produced by
ovaries, estradiol (an estrogen) which may reduce the risk of bone
loss, and norethindrone acetate (a progestin) which is necessary
when women with a uterus (womb) take estrogen.
For full prescribing information including Boxed Warning and
patient information, click here.
Indications and UsageMYFEMBREE is indicated for
the management of heavy menstrual bleeding associated with uterine
leiomyomas (fibroids) in premenopausal women. Limitations of Use:
Use of MYFEMBREE should be limited to 24 months due to the risk of
continued bone loss which may not be reversible.
Important Safety Information
BOXED WARNING: THROMBOEMBOLIC DISORDERS AND VASCULAR
EVENTS
Estrogen and progestin combination products, including
MYFEMBREE, increase the risk of thrombotic or thromboembolic
disorders including pulmonary embolism, deep vein thrombosis,
stroke and myocardial infarction, especially in women at increased
risk for these events.
MYFEMBREE is contraindicated in women with current or a
history of thrombotic or thromboembolic disorders and in women at
increased risk for these events, including women over 35 years of
age who smoke or women with uncontrolled hypertension.
CONTRAINDICATIONS
MYFEMBREE is contraindicated in women with any of the following:
high risk of arterial, venous thrombotic, or thromboembolic
disorder; pregnancy; known osteoporosis; current or history of
breast cancer or other hormone-sensitive malignancies; known
hepatic impairment or disease; undiagnosed abnormal uterine
bleeding; known hypersensitivity to components of MYFEMBREE.
WARNINGS AND PRECAUTIONS
Thromboembolic Disorders: Discontinue
immediately if an arterial or venous thrombotic, cardiovascular, or
cerebrovascular event occurs or is suspected. Discontinue at least
4 to 6 weeks before surgery associated with an increased risk of
thromboembolism, or during periods of prolonged immobilization, if
feasible. Discontinue immediately if there is sudden unexplained
partial or complete loss of vision, proptosis, diplopia,
papilledema, or retinal vascular lesions and evaluate for retinal
vein thrombosis as these have been reported with estrogens and
progestins.
Bone Loss: MYFEMBREE may cause a decrease
in bone mineral density (BMD) in some patients, which may be
greater with increasing duration of use and may not be completely
reversible after stopping treatment. Consider the benefits and
risks in patients with a history of low trauma fracture or risk
factors for osteoporosis or bone loss, including medications that
may decrease BMD. Assessment of BMD by dual-energy X-ray
absorptiometry (DXA) is recommended at baseline and periodically
thereafter. Consider discontinuing MYFEMBREE if the risk of bone
loss exceeds the potential benefit.
Hormone-Sensitive
Malignancies: Discontinue MYFEMBREE if a
hormone-sensitive malignancy is diagnosed. Surveillance measures in
accordance with standard of care, such as breast examinations and
mammography are recommended. Use of estrogen alone or estrogen plus
progestin has resulted in abnormal mammograms requiring further
evaluation.
Depression, Mood Disorders, and Suicidal
Ideation: Promptly evaluate patients with mood
changes and depressive symptoms including shortly after initiating
treatment, to determine whether the risks of continued therapy
outweigh the benefits. Patients with new or worsening depression,
anxiety, or other mood changes should be referred to a mental
health professional, as appropriate. Advise patients to seek
immediate medical attention for suicidal ideation and behavior and
reevaluate the benefits and risks of continuing MYFEMBREE.
Hepatic Impairment and Transaminase
Elevations: Steroid hormones may be poorly
metabolized in these patients. Instruct women to promptly seek
medical attention for symptoms or signs that may reflect liver
injury, such as jaundice or right upper abdominal pain. Acute liver
test abnormalities may necessitate the discontinuation of MYFEMBREE
use until the liver tests return to normal and MYFEMBREE causation
has been excluded.
Gallbladder Disease or History of Cholestatic
Jaundice: Discontinue MYFEMBREE if signs or symptoms
of gallbladder disease or jaundice occur. For women with a history
of cholestatic jaundice associated with past estrogen use or with
pregnancy, assess the risk-benefit of continuing therapy. Studies
among estrogen users suggest a small increased relative risk of
developing gallbladder disease.
Elevated Blood Pressure: For women with
well-controlled hypertension, monitor blood pressure and stop
MYFEMBREE if blood pressure rises significantly.
Change in Menstrual Bleeding Pattern and Reduced Ability
to Recognize Pregnancy: Advise women to use
non-hormonal contraception during treatment and for one week after
discontinuing MYFEMBREE. Avoid concomitant use of hormonal
contraceptives. MYFEMBREE may delay the ability to recognize
pregnancy because it alters menstrual bleeding. Perform testing if
pregnancy is suspected and discontinue MYFEMBREE if pregnancy is
confirmed.
Risk of Early Pregnancy Loss: MYFEMBREE
can cause early pregnancy loss. Exclude pregnancy before initiating
and advise women to use effective non-hormonal contraception.
Uterine Fibroid Prolapse or
Expulsion: Advise women with known or suspected
submucosal uterine fibroids about the possibility of uterine
fibroid prolapse or expulsion and instruct them to contact their
physician if severe bleeding and/or cramping occurs.
Alopecia: Alopecia, hair loss, and hair
thinning were reported in phase 3 trials with MYFEMBREE. Consider
discontinuing MYFEMBREE if hair loss becomes a concern. Whether the
hair loss is reversible is unknown.
Effects on Carbohydrate and Lipid
Metabolism: More frequent monitoring in
MYFEMBREE-treated women with prediabetes and diabetes may be
necessary. MYFEMBREE may decrease glucose tolerance and result in
increased blood glucose concentrations. Monitor lipid levels and
consider discontinuing if hypercholesterolemia or
hypertriglyceridemia worsens. In women with pre-existing
hypertriglyceridemia, estrogen therapy may be associated with
elevations in triglycerides levels leading to pancreatitis. Use of
MYFEMBREE is associated with increases in total cholesterol and
LDL-C.
Effect on Other Laboratory
Results: Patients with hypothyroidism and
hypoadrenalism may require higher doses of thyroid hormone or
cortisol replacement therapy. Use of estrogen and progestin
combinations may raise serum concentrations of binding proteins
(e.g., thyroid-binding globulin, corticosteroid-binding globulin),
which may reduce free thyroid or corticosteroid hormone levels. Use
of estrogen and progestin may also affect the levels of sex
hormone-binding globulin, and coagulation factors.
Hypersensitivity Reactions: Immediately
discontinue MYFEMBREE if a hypersensitivity reaction occurs.
ADVERSE REACTIONS
Most common adverse reactions for MYFEMBREE (incidence ≥3% and
greater than placebo) were hot flush/hyperhidrosis/night sweats,
abnormal uterine bleeding, alopecia, and decreased libido. These
are not all the possible side effects of MYFEMBREE.
DRUG INTERACTIONS
P-gp Inhibitors: Avoid use of MYFEMBREE
with oral P-gp inhibitors. If use is unavoidable, take MYFEMBREE
first, separate dosing by at least 6 hours, and monitor patients
for adverse reactions.
Combined P-gp and Strong CYP3A
Inducers: Avoid use of MYFEMBREE with combined P-gp
and strong CYP3A inducers.
LACTATIONAdvise women not to breastfeed while
taking MYFEMBREE.
About Myovant Sciences Myovant
Sciences aspires to redefine care for women and for men
through purpose-driven science, empowering medicines, and
transformative advocacy. Founded in 2016, Myovant has executed five
successful Phase 3 clinical trials across oncology and women’s
health leading to two regulatory approvals by the U.S. Food and
Drug Administration (FDA) for men with advanced prostate cancer and
women with heavy menstrual bleeding associated with uterine
fibroids, respectively. The company also has received regulatory
approvals by the European Commission (EC) for women with
symptomatic uterine fibroids and for men with advanced
hormone-sensitive prostate cancer. The company has a supplemental
New Drug Application in endometriosis-associated pain pending with
the U.S. FDA. Myovant also is conducting a Phase 3 study to
evaluate the prevention of pregnancy in women with uterine fibroids
or endometriosis. Myovant also is developing MVT-602, an
investigational oligopeptide kisspeptin-1 receptor agonist, which
has completed a Phase 2a study for female infertility as part of
assisted reproduction. Sumitovant Biopharma, Ltd., a wholly owned
subsidiary of Sumitomo Pharma Co., Ltd., is Myovant’s majority
shareholder. For more information, please
visit www.myovant.com. Follow @Myovant on Twitter
and LinkedIn.
About Pfizer: Breakthroughs That Change Patients’
LivesAt Pfizer, we apply science and our global resources
to bring therapies to people that extend and significantly improve
their lives. We strive to set the standard for quality, safety and
value in the discovery, development and manufacture of health care
products, including innovative medicines and vaccines. Every day,
Pfizer colleagues work across developed and emerging markets to
advance wellness, prevention, treatments and cures that challenge
the most feared diseases of our time. Consistent with our
responsibility as one of the world's premier innovative
biopharmaceutical companies, we collaborate with health care
providers, governments and local communities to support and expand
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In addition, to learn more, please visit us on www.Pfizer.com
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Myovant Sciences Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Myovant Sciences’ forward-looking statements are based on
management’s current expectations and beliefs and are subject to a
number of risks, uncertainties, assumptions, and other factors
known and unknown that could cause actual results and the timing of
certain events to differ materially from future results expressed
or implied by the forward-looking statements. In this press
release, forward-looking statements include, but are not limited
to, the statements with respect to MYFEMBREE’s potential to become
a therapeutic option for the management of endometriosis-associated
pain and Myovant’s plan to continue to work closely with the FDA to
support the ongoing review of the sNDA in Mr. Arjona Ferreira’s
quote.
For a further discussion of factors that could materially affect
Myovant Sciences’ operations and future prospects or which could
cause actual results to differ materially from expectations, see
the risks and uncertainties listed in Myovant Sciences’ filings
with the United States Securities and Exchange
Commission (SEC), including under the heading “Risk Factors”
in Myovant Sciences’ Quarterly Report on Form 10-Q filed
on January 26, 2022, as such risk factors may be amended,
supplemented, or superseded from time to time. These risks are not
exhaustive. New risk factors emerge from time to time and it is not
possible for Myovant Sciences’ management to predict all risk
factors, nor can Myovant Sciences assess the impact of
all factors on its business or the extent to which any factor, or
combination of factors, may cause actual results to differ
materially from those contained in any forward-looking statements.
You should not place undue reliance on the forward-looking
statements in this press release, which speak only as of the date
hereof, and, except as required by law, Myovant
Sciences undertakes no obligation to update these
forward-looking statements to reflect events or circumstances after
the date of such statements.
Pfizer Disclosure NoticeThe information
contained in this release is as of May 6, 2022. Pfizer assumes no
obligation to update forward-looking statements contained in this
release as the result of new information or future events or
developments.
This release contains forward-looking information about
MYFEMBREE® (relugolix 40 mg, estradiol 1 mg, and norethindrone
acetate 0.5 mg), including a potential indication in the U.S. for
the management of moderate to severe pain associated with
endometriosis, including its potential benefits, that involves
substantial risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by such
statements. Risks and uncertainties include, among other things,
uncertainties regarding the commercial success of MYFEMBREE; the
uncertainties inherent in research and development, including the
ability to meet anticipated clinical endpoints, commencement and/or
completion dates for clinical trials, regulatory submission dates,
regulatory approval dates and/or launch dates, as well as the
possibility of unfavorable new clinical data and further analyses
of existing clinical data; the risk that clinical trial data are
subject to differing interpretations and assessments by regulatory
authorities; whether regulatory authorities will be satisfied with
the design of and results from the clinical studies; whether and
when applications may be filed in any additional jurisdictions for
MYFEMBREE for the management of moderate to severe pain associated
with endometriosis or in any jurisdictions for any other potential
indications for MYFEMBREE; whether and when the FDA may approve the
supplemental new drug application for the management of moderate to
severe pain associated with endometriosis and whether and when
regulatory authorities in any jurisdictions may approve any such
other applications for MYFEMBREE that may be pending or filed,
which will depend on myriad factors, including making a
determination as to whether the product’s benefits outweigh its
known risks and determination of the product’s efficacy and, if
approved, whether MYFEMBREE will be commercially successful;
decisions by regulatory authorities impacting labeling,
manufacturing processes, safety and/or other matters that could
affect the availability or commercial potential of MYFEMBREE;
whether our collaboration with Myovant Sciences will be successful;
uncertainties regarding the impact of COVID-19 on Pfizer’s
business, operations and financial results; and competitive
developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2021 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
Myovant Sciences Contacts
Investor Contact:Uneek MehraChief Financial and
Business OfficerMyovant Sciences, Inc.investors@myovant.com
Media Contact:Noelle Cloud DuganVice President,
Corporate CommunicationsMyovant Sciences, Inc.media@myovant.com
Pfizer Contacts
Media
Relations:PfizerMediaRelations@Pfizer.com+1 (212)
733-1226
Investor Relations:IR@Pfizer.com+1 (212)
733-4848
________________________i Adamson, G. et al. Journal
Endometriosis. 2010; 2:3-6ii US census 2019 (table 1; approx. 75
million women in the US ages 15-49). Available online at
https://data.census.gov/cedsci/table?q=United%20States&t=Age%20and%20Sexiii
Shafrir. Best Pract Res Clin Obstet Gynaecol. 2018 Aug;51:1-15 iv
Fuldeore Gynecol Obstet Invest. 2017;82:453-461 v Zondervan KT, et
al. NEJM. 2020;382(13):1244–1256vi Nnoaham KE et al. Fertil Steril.
2011;96(2):366.e8–373.e8vii Ballard K et al. Fertil Steril.
2006;86:1296–301viii Soliman et al. J Women’s Health. 2017. 26(7):
788-797ix Becker CM, Gattrell WT, Gude K, Singh SS. Reevaluating
response and failure of medical treatment of endometriosis: a
systematic review. Fertil Steril. 2017 Jul;108(1):125-136
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