Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE)
announced today 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). The sNDA proposes updates
to MYFEMBREE’s 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 associated with uterine fibroids for up to
two years. The FDA set a target action date of January 29, 2023 for
this sNDA under the Prescription Drug User Fee Act (PDUFA).
“Heavy menstrual bleeding is the most common symptom affecting
women with uterine fibroids that can impact their daily life and
activities over a long period of time,” said Juan Camilo Arjona
Ferreira, M.D., Chief Medical Officer of Myovant Sciences, Inc. “We
are pleased to submit these study results to the FDA as they show
the value MYFEMBREE can potentially have on treating women’s
uterine fibroid symptoms long term.”
Patients who completed the 24-week pivotal LIBERTY 1 and 2
studies were offered the option to receive MYFEMBREE for an
additional 28 weeks in an open-label extension study. After
completion of the LIBERTY 1 or LIBERTY 2 and the open-label
extension studies, women who met the definition of responder
(menstrual blood loss < 80 mL and a reduction from pivotal study
baseline > 50%) could participate in an additional 52-week
randomized withdrawal study (N=229) designed to provide two-year
safety and efficacy data on MYFEMBREE and to evaluate the need for
maintenance therapy. Women who entered the RWS were re-randomized
to either MYFEMBREE or placebo for 52 additional weeks (N = 229),
with the primary endpoint at Week 76.
The LIBERTY randomized withdrawal study met its primary
endpoint with 78.4% of women who continued on MYFEMBREE achieving
the sustained responder rate (menstrual blood loss < 80 mL)
through Week 76 compared with 15.1% of women who discontinued
treatment and initiated placebo at Week 52 (p < 0.0001). All
three key secondary endpoints in the LIBERTY randomized
withdrawal study were also achieved, including sustained responder
rate through Week 104, time to relapse of heavy menstrual bleeding,
and amenorrhea rate (all p < 0.0001).
Bone mineral density remained stable in women who received
MYFEMBREE in the randomized withdrawal study. Additionally, bone
mineral density was maintained through two years in the subset of
women continuously treated with MYFEMBREE (N = 31). The incidence
of adverse events over one additional year of treatment was
consistent with those observed in prior studies, with no new safety
signals observed.
“Data from the MYFEMBREE RWS supports our mission to improve
care for women living with uterine fibroids,” 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 the FDA’s review of the
application and potential updates to the MYFEMBREE prescribing
information based on these data.”
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 the Phase 3 LIBERTY Program in Uterine
Fibroids The Phase 3 clinical program for uterine
fibroids consisted of two multi-national, replicate pivotal
clinical studies (LIBERTY 1, N=388 and LIBERTY 2,
N=382) of MYFEMBREE® in women with heavy menstrual bleeding
associated with uterine fibroids for 24 weeks. Eligible women who
completed the LIBERTY 1 or LIBERTY 2 studies
were offered the opportunity to enroll in an active treatment,
open-label extension study in which all women received MYFEMBREE
for an additional 28-week period for a total treatment period of 52
weeks (N=477), designed to evaluate the safety and efficacy of
longer-term treatment. After completion of the LIBERTY 1 or LIBERTY
2 and open-label extension studies, eligible women could elect to
participate in an additional 52-week randomized withdrawal study
(N=229) designed to provide two-year safety and efficacy data on
MYFEMBREE and to evaluate the need for maintenance therapy. Across
the LIBERTY 1, LIBERTY 2 and open-label extension studies, a
response was defined as a menstrual blood loss volume of less than
80 mL and a 50% or greater reduction from baseline in menstrual
blood loss volume during the last 35 days of treatment measured
using the alkaline hematin method.
LIBERTY 1 and LIBERTY 2 met their primary endpoints (p <
0.0001) with 72.1% and 71.2% of women receiving MYFEMBREE achieving
the responder criteria compared with 16.8% and 14.7% of women
receiving placebo at 24 weeks, respectively. On average, women
receiving MYFEMBREE in both studies experienced an 84.3% reduction
in menstrual blood loss from baseline at Week 24 (p < 0.0001).
The overall incidence of adverse events in the relugolix
combination and placebo groups was comparable in both studies. The
most common adverse reactions (incidence ≥ 3%) were hot flush,
hyperhidrosis or night sweats, uterine bleeding, alopecia, and
decreased libido.
In the open-label extension study, changes in bone mineral
density through one year, as assessed by DXA every three months,
were consistent with LIBERTY 1 and 2. The incidence of
adverse events over one year was consistent with that observed
in LIBERTY 1 and 2, with no new safety signals
observed.
The LIBERTY randomized withdrawal study met its
primary endpoint of maintaining sustained responder rate (menstrual
blood loss < 80 mL). All three key secondary endpoints in
the LIBERTY randomized withdrawal study were also
achieved, including sustained responder rate at two years (Week
104), time to relapse of heavy menstrual bleeding, and amenorrhea
rate (all p < 0.0001). Bone mineral density was maintained
through two years in the subset of women continuously treated with
MYFEMBREE (N = 31). The incidence of adverse events over one
additional year of treatment was consistent with those observed in
prior studies, with no new safety signals observed.
About Uterine FibroidsUterine fibroids are
noncancerous tumors that develop in or on the muscular walls of the
uterus and are among the most common reproductive tract tumors in
women. In addition to an individual's genetic predisposition,
estrogens are well known to play an important role in the
regulation of fibroid growth.
Although uterine fibroids are benign tumors, they can cause
debilitating symptoms such as heavy menstrual bleeding (frequently
resulting in anemia and fatigue), pain (including painful periods,
abdominal pain, painful intercourse, backache), increased abdominal
girth and bloating, urinary frequency or retention, constipation,
pregnancy loss, and, in some cases, infertility. These symptoms can
also lead to loss of productivity at work, limitations in normal
activities of daily living, and social embarrassment.
An estimated five million women in the U.S. suffer
from symptoms of uterine fibroids,i and an estimated three million
women are inadequately treated by current medical therapy.ii
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 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 the value of MYFEMBREE on
treating women's uterine fibroid symptoms, the potential updates to
the MYFEMBREE USPI, and the potential outcome of FDA’s review of
the sNDA for MYFEMBREE.
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 2, 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 sNDA proposing updates to the United
States Prescribing Information 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, 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
RWS study data or in any jurisdictions for any other potential
indications for MYFEMBREE; 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 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
i Stewart E. Lancet. 2001. 357:293-298ii Marjoribanks et al.
Cochrane Database Syst. Rev. 2006.
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