Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE)
today announced that the U.S. Food and Drug Administration (FDA)
accepted for review a 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 set a target action date of
May 6, 2022 for this sNDA under the Prescription Drug User Fee Act
(PDUFA).
“Women with endometriosis often experience debilitating symptoms
that impact their daily lives – and unfortunately, many of them do
not find relief with the medical options that are currently
available,” said Juan Camilo Arjona Ferreira, M.D., Chief Medical
Officer of Myovant Sciences, Inc. “If approved for this
indication, we believe MYFEMBREE has the potential to redefine care
for women with endometriosis as an effective, one pill, once-a-day
treatment option.”
The sNDA submission in endometriosis is supported by results
from the Phase 3 SPIRIT program, which included two multinational,
replicate pivotal clinical studies (SPIRIT 1 and SPIRIT 2) in over
1,200 women with pain associated with endometriosis for 24 weeks,
and an open-label extension study for eligible women who completed
either SPIRIT 1 or SPIRIT 2 through one year.
“The submission of the sNDA for MYFEMBREE to treat endometriosis
pain reflects our commitment to addressing areas of significant
unmet need in women’s health,” said James Rusnak, M.D., Ph.D.,
Senior Vice President, Chief Development Officer, Internal Medicine
and Hospital, Global Product Development at Pfizer. “We
look forward to potentially bringing this important new treatment
option to women with endometriosis.”
In the U.S., MYFEMBREE is currently available for the management
of heavy menstrual bleeding associated with uterine fibroids in
premenopausal women, with a treatment duration of up to 24 months.
The FDA approved MYFEMBREE for this indication on May 26,
2021, based on data from the Phase 3 LIBERTY program. Myovant and
Pfizer are jointly developing and commercializing MYFEMBREE in the
U.S.
About EndometriosisEndometriosis is an
estrogen-dependent, inflammatory disease in which tissue similar to
the uterine lining is found outside the uterine cavity, commonly in
the lower abdomen or pelvis, on ovaries, the bladder, and the
colon. This endometrial-like tissue outside the uterus results in
chronic inflammation and can cause scarring and adhesions.
The symptoms associated with endometriosis include painful
periods and chronic pelvic pain, painful ovulation, pain during or
after sexual intercourse, heavy bleeding, fatigue, and infertility.
Endometriosis can also impact general physical, mental, and social
well-being, requiring a multi-disciplinary approach to care.
For endometriosis-associated pain, per current guidelines,
initial treatment options include hormonal contraceptives and
over-the-counter pain medications. In more severe cases, LHRH
agonists such as leuprolide acetate are used for short-term
treatment. An estimated six million women in
the U.S. suffer from symptoms of endometriosis, and an
estimated one million women are inadequately treated by current
medical therapy and require further treatment. Almost 200 million
women are affected globally.
About MYFEMBREE®MYFEMBREE
(relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg)
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, please 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 REACTIONSMost 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 INTERACTIONSP-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, we have two
FDA-approved products. ORGOVYX® (relugolix) was approved by
the U.S. Food and Drug Administration in 2020 as the
first and only oral gonadotropin-releasing hormone (GnRH) receptor
antagonist for the treatment of adult patients with advanced
prostate cancer, and relugolix is also under regulatory review
in Europe for men with advanced prostate
cancer. Relugolix combination tablet (relugolix 40 mg,
estradiol 1.0 mg, and norethindrone acetate 0.5 mg) was approved in
2021 in the U.S. as MYFEMBREE® as the first
once-daily treatment for the management of heavy menstrual bleeding
associated with uterine fibroids in premenopausal women, and by the
European Commission as RYEQO® for the treatment of moderate to
severe symptoms of uterine fibroids in adult women of reproductive
age. The therapy has also completed Phase 3
registration-enabling studies for women with endometriosis and is
being assessed for the prevention of pregnancy. We are also
developing MVT-602, an 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 Dainippon Pharma Co., Ltd., is our
majority shareholder. For more information, please visit our
website at www.myovant.com. Follow @Myovant on
Twitter and LinkedIn.
About Pfizer: Breakthroughs That Change Patients’
Lives At 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
access to reliable, affordable health care around the world. For
more than 170 years, we have worked to make a difference for all
who rely on us. We routinely post information that may be important
to investors on our website at www.Pfizer.com. In addition, to
learn more, please visit us on www.Pfizer.com and follow us on
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Myovant Sciences Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. In
this press release, forward-looking statements include, but are not
limited to, all statements reflecting Myovant Sciences’
expectations, including: statements regarding Myovant’s aspiration
to redefine care for women and for men; Myovant’s expectations
regarding the potential benefits of MYFEMBREE for the management of
moderate to severe pain associated with endometriosis; and
Myovant’s expectations regarding the development and
commercialization of MYFEMBREE by Myovant and Pfizer in the United
States.
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, including unforeseen
circumstances or other disruptions to normal business operations
arising from or related to the COVID-19 pandemic. Myovant Sciences
cannot assure you that the events and circumstances reflected in
the forward-looking statements will be achieved or occur and actual
results could differ materially from those expressed or implied by
these forward-looking statements. Factors that could materially
affect Myovant Sciences’ operations and future prospects or which
could cause actual results to differ materially from expectations
include, but are not limited to 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 July 28, 2021, 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 September 9, 2021. 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) 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, 2020 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 ContactsRyan Crowe,
Investors+1 (650) 781-9106investors@myovant.com
Albert Liao, Media+1 (650) 410-3055media@myovant.com
Pfizer ContactsMedia Relations Steve Danehy+1
(212) 733-1538PfizerMediaRelations@pfizer.com
Investor Relations Bryan Dunn+1 (212)
733-8917Bryan.Dunn@Pfizer.com
Pfizer (NYSE:PFE)
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