Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today
announced that results of the Phase 3 SPIRIT 1 and SPIRIT 2 studies
of investigational once-daily relugolix combination therapy
(relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate
0.5 mg) in over 1,200 women with moderate to severe pain associated
with endometriosis were published in The Lancet.
As previously reported, both studies achieved their co-primary
endpoints by demonstrating clinically meaningful reductions in
dysmenorrhea (menstrual pain) and non-menstrual pelvic pain in
women with endometriosis. SPIRIT 1 and 2 each met their co-primary
endpoints with 75% of women in the relugolix combination therapy
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, relugolix combination therapy achieved a
clinically meaningful reduction in 59% and 66% of women, compared
with 40% and 43% of women in the placebo groups (p < 0.0001). In
SPIRIT 1, seven key secondary endpoints, and in SPIRIT 2, six key
secondary endpoints comparing relugolix combination therapy with
placebo at Week 24 achieved statistical significance, including
reductions in dyspareunia and opioid use. In addition, more women
treated with relugolix combination therapy groups were opioid free
at Week 24 compared with placebo (86% and 82% vs 76% and 66%,
respectively). In both studies, relugolix combination therapy was
associated with a generally well-tolerated safety profile,
including bone mineral density loss of <1% over 24 weeks.
“Approximately 7.5 million premenopausal women in the United
States have endometriosis and 75-80 percent of them are
symptomatic,” said Juan Camilo Arjona Ferreira, M.D., Chief Medical
Officer of Myovant Sciences, Inc.1,2,3,4 “The data published in The
Lancet underscore the value relugolix combination therapy may
provide as a potential new treatment option for women with
endometriosis-associated pain.”
“We are excited to see this data published in The Lancet,” said
James Rusnak, M.D., Ph.D., Senior Vice President, Chief Development
Officer, Internal Medicine and Hospital, Global Product Development
at Pfizer. “We continue to look forward to bringing this potential
new treatment option to women with endometriosis-associated
pain.”
Seven key secondary endpoints in SPIRIT 1 and six key secondary
endpoints in SPIRIT 2 comparing relugolix combination therapy with
placebo at Week 24 also achieved statistical significance. These
endpoints include changes in mean dysmenorrhea, non-menstrual
pelvic pain, overall pelvic pain, impact of pain on daily
activities as measured by the Endometriosis Health Profile-30
(EHP-30) pain domain, the proportion of women not using opioids,
the proportion of women not using analgesics, and change in mean
dyspareunia (painful intercourse). While the seventh endpoint for
the SPIRIT 2 study – reduction in analgesic use (based on pill
count) – did not achieve statistical significance, possibly due to
the low number of average pills per day and variability in
day-to-day pill consumption, a post-hoc analysis of SPIRIT 2 showed
that the percentage of patients who were analgesic-free at end of
treatment was greater among women in the combination therapy group
than the placebo group.
The most frequently reported adverse events in both relugolix
combination treatment and placebo groups were headache,
nasopharyngitis, and hot flushes.
In the U.S., relugolix combination tablet (relugolix 40 mg,
estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is currently
available as MYFEMBREE® for the management of heavy menstrual
bleeding associated with uterine fibroids in premenopausal women,
with a treatment duration of up to 24 months. Data from SPIRIT 1
and SPIRIT 2, in addition to data from an open-label extension
study, were included in a supplemental New Drug Application for
MYFEMBREE for the management of moderate to severe pain associated
with endometriosis, which has a target Prescription Drug User Fee
Act (PDUFA) action date of August 6, 2022.
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,
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.5 In the U.S., there are approximately 7.5
million premenopausal women with endometriosis.1,2,3 It can
take between four and eleven years to get an endometriosis
diagnosis6,7,8 and for some women, current treatment options
do not provide relief.9
About MYFEMBREE®MYFEMBREE (relugolix,
estradiol, and norethindrone acetate) is the first and only
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 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, 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. Myovant 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. Myovant has supplemental
New Drug Applications under review with the FDA for
endometriosis-associated pain, and 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’
LivesAt Pfizer, we apply science and our global resources
to bring therapies to people that extend and significantly improve
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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.
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 providing relugolix combination
therapy as a potential new treatment option for women with
endometriosis-associated pain.
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’
Annual Report on Form 10-K filed on May 11, 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 June 17,
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 for the management of moderate to
severe pain associated with endometriosis 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 OfficerMyovant
Sciences, Inc.investors@myovant.com
Media Contact:Noelle Cloud DuganVice President,
Corporate CommunicationsMyovant Sciences, Inc.media@myovant.com
Pfizer ContactsMedia
Relations:PfizerMediaRelations@Pfizer.com+1 (212)
733-1226
Investor Relations:IR@Pfizer.com+1 (212)
733-4848
1. 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%20Sex2.
Shafrir. Best Pract Res Clin Obstet Gynaecol. 2018
Aug;51:1-153. Fuldeore Gynecol Obstet Invest.
2017;82:453-4614. Bulletti J Asist Reprod Genet
20105. Adamson, G. et al. Journal Endometriosis. 2010;
2:3-66. Zondervan KT, et al. NEJM.
2020;382(13):1244–12567. Nnoaham KE et al. Fertil
Steril. 2011;96(2):366.e8–373.e88. Ballard K et al.
Fertil Steril. 2006;86:1296–3019. Soliman et al. J
Women’s Health. 2017. 26(7): 788-797
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