Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE)
today announced that the U.S. Food and Drug
Administration (FDA) has approved MYFEMBREE® (relugolix 40 mg,
estradiol 1 mg, and norethindrone acetate 0.5 mg) as a one-pill,
once-a-day therapy for the management of moderate to severe pain
associated with endometriosis in pre-menopausal women, with a
treatment duration of up to 24 months. The approval is supported by
one-year efficacy and safety data, including 24-week data from the
Phase 3 SPIRIT 1 and SPIRIT 2 trials, which were published in The
Lancet, and the first 28 weeks of an open-label extension study for
eligible women who completed either SPIRIT 1 or SPIRIT 2. MYFEMBREE
also is approved for heavy menstrual bleeding associated with
uterine fibroids in pre-menopausal women. Myovant and Pfizer will
continue to jointly commercialize MYFEMBREE in the U.S. and product
is available immediately.
“Endometriosis is a painful, chronic disease with limited
therapies to manage symptoms,” said Juan Camilo Arjona Ferreira,
M.D., Chief Medical Officer of Myovant Sciences, Inc. “The new
MYFEMBREE indication helps advance our mission to redefine care for
women by helping address a disease with high unmet need, giving
women and physicians a new meaningful treatment option to manage
moderate to severe pain associated with endometriosis.”
“This approval is an important milestone reflecting Pfizer and
Myovant’s commitment to women’s health in areas of significant
unmet need,” 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 making MYFEMBREE available to women with endometriosis
and broadening their options in managing this complex
disorder.”
MYFEMBREE offers an effective, once-daily treatment option for
the management of moderate to severe pain associated with
endometriosis, with a treatment duration of up to 24 months.
Endometriosis is a serious chronic condition that requires
long-term interventions. Optimization of medical therapies is the
recommended treatment paradigm.1,2,3 MYFEMBREE introduces an
option for up to two years of pharmacological management of
moderate to severe pain associated with endometriosis in
pre-menopausal women.
“The data from the SPIRIT studies showed the clinical benefit
that relugolix combination therapy can have on moderate to severe
pain associated with endometriosis and how it can impact patients,”
said Linda Giudice, M.D., Ph.D., Distinguished Professor at the
University of California, San Francisco (UCSF), and Chair, SPIRIT
Program Steering Committee. “This newly approved option for
patients with pain from endometriosis offers the convenience of one
pill taken once daily with a mean change in bone mineral density of
<1% that did not appear to worsen at 12 months of treatment;
however, monitoring is recommended.”
This approval is supported by one-year data from the Phase 3
SPIRIT program, which included two 24-week multi-national clinical
studies (SPIRIT 1 and SPIRIT 2) in more than 1,200 women with pain
associated with endometriosis, as well as the first 28 weeks of an
open-label extension study to assess its longer-term use. Overall,
these studies showed MYFEMBREE reduced menstrual pain and
non-menstrual pelvic pain with a loss of mean bone mineral density
of less than 1% from baseline through one year of treatment.4
SPIRIT 1 and 2 each met their co-primary endpoints with 75% of
women in the MYFEMBREE group in both studies achieving a clinically
meaningful reduction in dysmenorrhea compared with 27% and 30% of
women in the placebo groups at Week 24, respectively (both p
<0.0001). For non-menstrual pelvic pain, treatment with
MYFEMBREE demonstrated a clinically meaningful reduction in pain in
59% and 66% of women, compared with 40% and 43% of women in the
placebo groups (p < 0.0001). Adverse reactions occurring in at
least 3% of women treated with MYFEMBREE and greater than placebo
were: headache, vasomotor symptoms, mood disorders, abnormal
uterine bleeding, nausea, toothache, back pain, decreased sexual
desire and arousal, arthralgia, fatigue, and dizziness.
The open-label extension study for eligible women who completed
either SPIRIT 1 or SPIRIT 2 showed mean bone mineral density loss
of less than 1% from baseline through one year of treatment; some
patients (19.7%) had losses >3%. Annual bone density measurement
is recommended while treating women for endometriosis.
MYFEMBREE is available immediately to patients with moderate to
severe pain associated with endometriosis with a prescription from
their healthcare provider. Myovant and Pfizer also are committed to
supporting women in the U.S. who are prescribed MYFEMBREE
throughout their treatment journeys. The MYFEMBREE Support Program
provides access support services, including insurance benefits
checks, prior authorization support, co-pay support for
commercially insured patients, and patient assistance for
qualifying uninsured patients. Program terms and conditions apply.
For more information and additional resources, please contact
833-MYFEMBREE (833-693-3627), 8 a.m. – 8 p.m. Eastern Time, Monday
– Friday.
Myovant Conference CallMyovant will hold a
conference call on Monday, August 8, 2022, at 8:30 a.m. Eastern
Time / 5:30 a.m. Pacific Time to discuss the FDA approval of
MYFEMBREE for the management of moderate to severe pain associated
with endometriosis. Investors and the general public may access the
live webcast here. The live webcast can also be accessed by
visiting the company’s investor relations page of Myovant’s website
at: https://investors.myovant.com/.
About EndometriosisEndometriosis 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,
combined oral contraceptives, progestins, danazol, GnRH agonists
and antagonists, and surgical interventions.
Endometriosis can also impact general physical, mental, and
social well-being, requiring a multi-disciplinary approach to care.
Approximately 190 million women suffer from symptoms of
endometriosis globally.5 In the U.S., there are approximately 7.5
million premenopausal women with endometriosis and approximately
75-80 percent of them are symptomatic.6,7,8,9 Many women with pain
associated with endometriosis are not able to manage their pain
symptoms with current treatment options, underscoring the high
unmet need for this disease.10 It can take between four and eleven
years to get an endometriosis diagnosis11,12,13 and for some women,
current treatment options do not provide relief.14
About MYFEMBREE®MYFEMBREE
(relugolix, estradiol, and norethindrone acetate) is a once-daily
oral treatment approved by the U.S. Food and Drug
Administration for the management of moderate to severe pain
associated with endometriosis, with a treatment duration of up to
24 months. It is also currently available in the U.S. for the
management of heavy menstrual bleeding associated with uterine
fibroids in premenopausal women, 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 in
premenopausal women for the management of:
- Heavy menstrual bleeding associated with uterine leiomyomas
(fibroids)
- Moderate to severe pain associated with endometriosis
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.
CONTRAINDICATIONSMYFEMBREE 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 PRECAUTIONSThromboembolic
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 in all women.
During treatment, periodic DXA is recommended for women with heavy
menstrual bleeding due to uterine fibroids; in those with moderate
to severe endometriosis pain, annual DXA is recommended. 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.
Suicidal Ideation and Mood Disorders (Including
Depression): Evaluate patients with a history of suicidal
ideation, depression, and mood disorders prior to initiating
treatment. Monitor patients for mood changes and depressive
symptoms including shortly after initiating treatment, to determine
whether the risks of continuing therapy with MYFEMBREE 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.
Gonadotropin-releasing hormone receptor antagonists, including
MYFEMBREE, have been associated with mood disorders (including
depression) and suicidal ideation.
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:
- Heavy menstrual bleeding associated with uterine fibroids:
vasomotor symptoms, abnormal uterine bleeding, alopecia, and
decreased libido.
- Moderate to severe pain associated with endometriosis:
headache, vasomotor symptoms, mood disorders, abnormal uterine
bleeding, nausea, toothache, back pain, decreased sexual desire and
arousal, arthralgia, fatigue, and dizziness.
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.
LACTATION: Advise 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 three regulatory approvals by
the U.S. Food and Drug Administration (FDA) for men with
advanced prostate cancer, women with heavy menstrual bleeding
associated with uterine fibroids, and pre-menopausal women with
moderate to severe pain associated with endometriosis,
respectively. Myovant also has received regulatory
approvals by the European Commission (EC) and the United
Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA)
for women with symptomatic uterine fibroids and for men with
advanced hormone-sensitive prostate cancer. Myovant has a
supplemental New Drug Application under review with the FDA for
updates to the United States Prescribing Information (USPI) based
on safety and efficacy data from the Phase 3 LIBERTY randomized
withdrawal study (RWS) of MYFEMBREE in premenopausal women with
heavy menstrual bleeding due to uterine fibroids for up to two
years. 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’
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 Twitter
at @Pfizer and @PfizerNews, LinkedIn, YouTube and
like us on Facebook at Facebook.com/Pfizer.
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; the expectations regarding
the continued commercialization of MYFEMBREE by Myovant and Pfizer
jointly in the U.S. and the timeline of product availability; the
expectations that MYFEMBREE’s indication helps advance Myovant’s
mission to redefine care for women by helping address a disease
with high unmet need, giving women and physicians a new meaningful
treatment option to manage moderate to severe pain associated with
endometriosis in Dr. Arjona Ferreira’s quote; the expectation of
making MYFEMBREE available to women with endometriosis and
broadening their options in managing this complex disorder in Dr.
Rusnak’s quote; and the expectations of the MYFEMBREE Support
Program for patients and the features of such program.
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 and the conflict
in Ukraine. 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 27, 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 August 5,
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), a new indication in the U.S. for the management of
moderate to severe pain associated with endometriosis in
pre-menopausal women, and a collaboration between Pfizer and
Myovant Sciences to develop and commercialize relugolix in advanced
prostate cancer and women’s health, including their 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 for any other potential indications for MYFEMBREE;
whether and when regulatory authorities may approve any such
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 ContactsInvestor
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
RelationsPfizerMediaRelations@Pfizer.com+1 (212) 733-1226
Investor RelationsIR@Pfizer.com+1 (212) 733-4848
1 American Society for Reproductive Medicine (ASRM), Treatment
of pelvic pain associated with endometriosis: a committee opinion.
Fertil Steril. 2014;101(4):927-35.2 Becker CM et al. ESHRE
guideline: endometriosis, Human Reproduction Open. 2022 Feb
26;2022(2): hoac009.3 Taylor HS et al. Endometriosis is a chronic
systemic disease: clinical challenges and novel innovations. Lancet
2021;397(10276):839-52 4 Giudice LC, et al. Lancet. 2022 Jun;
399(10343): 2267-2279.5 Adamson, G. et al. Journal Endometriosis.
2010; 2:3-66 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%20Sex7
Shafrir. Best Pract Res Clin Obstet Gynaecol. 2018 Aug; 51:1-158
Fuldeore Gynecol Obstet Invest. 2017;82:453-4619 Bulletti J Asist
Reprod Genet 201010 Becker CM, et al. Fertil Steril. 2017
Jul;108(1):125-136.11 Zondervan KT, et al. NEJM.
2020;382(13):1244–125612 Nnoaham KE et al. Fertil Steril.
2011;96(2):366.e8–373.e813 Ballard K et al. Fertil Steril.
2006;86:1296–30114 Soliman et al. J Women’s Health. 2017. 26(7):
788-797
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