Myovant Sciences (NYSE: MYOV), a healthcare company focused on
redefining care for women and for men, today announced that it has
submitted a New Drug Application (NDA) to the U.S. Food and
Drug Administration (FDA) for its once-daily relugolix
combination tablet (relugolix 40 mg, estradiol 1.0 mg, and
norethindrone acetate 0.5 mg) for the treatment of women with heavy
menstrual bleeding associated with uterine fibroids.
“An estimated five million women in the U.S. suffer from
symptoms of uterine fibroids, which may include heavy menstrual
bleeding, pain, and anemia – yet effective non-invasive treatment
options are very limited,” said Lynn Seely, M.D., chief executive
officer of Myovant Sciences. “If approved, we hope to redefine
care for these women with relugolix combination tablet, a potential
new treatment that demonstrated a predictable and
clinically-meaningful reduction in menstrual blood loss while
maintaining bone health in the Phase 3 LIBERTY program.”
The NDA submission in uterine fibroids is supported by positive
results from the Phase 3 LIBERTY program, which included two
multinational replicate studies and an open-label extension study
through one year. The NDA is the third regulatory application
Myovant has submitted this year, following a Marketing
Authorization Application to the European Medicines Agency in
uterine fibroids and an NDA in advanced prostate cancer. Myovant is
also advancing the Phase 3 SPIRIT program, evaluating relugolix
combination therapy (relugolix 40 mg plus estradiol 1.0 mg and
norethindrone acetate 0.5 mg) in women with pain associated with
endometriosis, with data from a second Phase 3 study expected this
quarter. SPIRIT 2, the first of the two Phase 3 studies of
once-daily relugolix combination therapy in women with pain
associated with endometriosis, met its co-primary efficacy
endpoints and six key secondary endpoints. In addition, relugolix
combination therapy was generally well-tolerated including minimal
bone mineral density loss over 24 weeks.
About the Phase 3 LIBERTY Program in Uterine
Fibroids Myovant’s Phase 3 clinical program for uterine
fibroids consisted of two multinational, replicate pivotal clinical
studies (LIBERTY 1 and LIBERTY 2) of relugolix combination therapy
(relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate
0.5 mg) 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 extension study in which all women
received relugolix combination therapy for an additional 28-week
period for a total treatment period of 52 weeks, designed to
evaluate the safety and efficacy of longer-term treatment. Upon
completion of this 52-week total treatment period, eligible women
could elect to participate in a second 52-week randomized
withdrawal study designed to provide two-year safety and efficacy
data on relugolix combination therapy and to evaluate the need for
maintenance therapy. Across 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 2 met their primary endpoints (p < 0.0001) with
73.4% and 71.2% of women receiving relugolix combination therapy
achieving the responder criteria compared with 18.9% and 14.7% of
women receiving placebo at 24 weeks, respectively. On average,
women receiving relugolix combination therapy in both studies
experienced an 84.3% reduction in menstrual blood loss from
baseline at Week 24 (p < 0.0001). Bone mineral density was
comparable between the relugolix combination therapy and placebo
groups in LIBERTY 1 and 2. The distribution of the change in bone
mineral density, including outliers, was similar for the relugolix
combination therapy and placebo groups at 24 weeks, as assessed by
dual energy x-ray absorptiometry (DXA). The overall incidence of
adverse events in the relugolix combination and placebo groups was
comparable in both studies.
The open-label extension study also met its primary endpoint
with relugolix combination therapy demonstrating an 87.7% response
rate at one year, showing the durability of the response observed
in LIBERTY 1 and 2. In addition, women experienced, on average, an
89.9% reduction in menstrual blood loss from baseline at Week 52.
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.
About Uterine Fibroids Uterine 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, and an estimated three million
women are inadequately treated by current medical therapy and
require further treatment.
About Relugolix Relugolix is a once-daily, oral
gonadotropin-releasing hormone (GnRH) receptor antagonist that
reduces ovarian estradiol production, a hormone known to stimulate
the growth of uterine fibroids and endometriosis, and testicular
testosterone production, a hormone known to stimulate the growth of
prostate cancer. Myovant is developing a relugolix combination
tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone
acetate 0.5 mg) for women with uterine fibroids and for women with
endometriosis. Myovant is also developing a relugolix
monotherapy tablet (120 mg once daily) for men with advanced
prostate cancer.
About Myovant Sciences Myovant
Sciences aspires to be the leading healthcare company focused
on redefining care for women and for men. The company’s lead
product candidate is relugolix, a once-daily, oral GnRH receptor
antagonist. The company has three late-stage clinical programs
for relugolix in uterine fibroids, endometriosis, and prostate
cancer. The company is also developing MVT-602, an oligopeptide
kisspeptin-1 receptor agonist, that has completed a Phase 2a study
for the treatment of female infertility as part of assisted
reproduction. Takeda Pharmaceuticals International AG, a
subsidiary of Takeda Pharmaceutical Company Limited, the originator
of relugolix, previously granted the company a worldwide
license to develop and commercialize relugolix
(excluding Japan and certain other Asian countries) and
an exclusive license to develop and commercialize MVT-602 in all
countries worldwide. Sumitovant Biopharma, Ltd., a wholly
owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is the
majority shareholder of Myovant. For more information, please
visit the company’s website at www.myovant.com.
Follow @Myovant on Twitter and LinkedIn.
Forward-Looking Statements This press-release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements include all statements regarding Myovant Sciences’
intent, belief, or expectations regarding future events or results
and can be identified by words such as “anticipate,” “aspire,”
“believe,” “can,” “continue,” “could,” “estimate,” “expect,”
“intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,”
“potential,” “predict,” “project,” “should,” “to be,” “will,”
“would,” or the negative or plural of these words or other similar
expressions or variations, although not all forward-looking
statements contain these identifying words. In this press release,
forward-looking statements include, but are not limited to,
statements and quotes regarding Myovant Sciences’ aspirations to
redefine care for women and men; the potential of relugolix
combination tablet, if approved, to be the first once-daily, oral
treatment for women with heavy menstrual bleeding associated with
uterine fibroids in the U.S., redefine care for women and achieve a
predictable and clinically-meaningful reduction in menstrual blood
loss while maintaining bone health; any expectations regarding the
approval of relugolix combination tablet and the timing of any
approval; any anticipated market size; and the expected timing of
data for the second Phase 3 study in women with endometriosis.
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. 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’ Annual Report on Form 10-K filed on May
18, 2020, 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.
Investor Contact: Frank Karbe President and
Chief Financial Officer Myovant Sciences, Inc.
investors@myovant.com
Media Contact: Albert Liao Director,
Corporate Communications Myovant Sciences, Inc.
media@myovant.com
Myovant Sciences (NYSE:MYOV)
Historical Stock Chart
From Mar 2024 to Apr 2024
Myovant Sciences (NYSE:MYOV)
Historical Stock Chart
From Apr 2023 to Apr 2024