Sumitovant Biopharma is pleased to announce that the U.S. Food and
Drug Administration (FDA) has accepted for Priority Review,
the New Drug Application (NDA) submitted by Myovant
Sciences (NYSE: MYOV), for once-daily, oral relugolix (120 mg)
for the treatment of men with advanced prostate cancer.
Myovant, a member of the Sumitovant family of companies, is a
healthcare company focused on redefining care for women and for
men.
“We are delighted that the FDA has accepted for Priority Review
our New Drug Application for relugolix, bringing us one step closer
to providing a one pill, once-a-day potential new treatment option
to men with advanced prostate cancer,” said Lynn Seely, M.D., chief
executive officer of Myovant Sciences. “As recently
published in the New England Journal of Medicine, relugolix
demonstrated superior efficacy and a 54% lower risk of major
adverse cardiovascular events compared to the current standard of
care, leuprolide acetate injections, in the Phase 3 HERO
study.”
“The FDA’s Priority Review designation as well as our
peer-reviewed Relugolix data validates the importance of
Sumitovant’s and its family of companies novel approach to drug
development of therapies with the potential to address critical
unmet needs,” said Sam Azoulay, chief medical officer of Sumitovant
Biopharma.
The FDA grants Priority Review to applications for potential
therapies that, if approved, would be significant improvements in
the safety or effectiveness of the treatment, diagnosis, or
prevention of serious conditions when compared to standard
applications. The FDA has set a target action date of December 20,
2020 under the Prescription Drug User Fee Act (PDUFA). In its
acceptance letter, the FDA also stated that it is currently not
planning to hold an advisory committee meeting for this
application. If approved, relugolix would be the first and only
oral gonadotropin-releasing hormone (GnRH) receptor antagonist
treatment for men with advanced prostate cancer.
In May 2020, Myovant submitted a separate NDA for once-daily,
oral relugolix combination tablet (relugolix 40 mg, estradiol 1.0
mg, and norethindrone acetate 0.5 mg) for women with heavy
menstrual bleeding associated with uterine fibroids. A Marketing
Authorization Application for relugolix combination tablet in women
with moderate to severe symptoms associated with uterine fibroids
is also under review by the European Medicines Agency.
About the Phase 3 HERO Program in Advanced Prostate
Cancer Myovant’s Phase 3 clinical program for advanced
prostate cancer consisted of a randomized, open-label,
parallel-group, multinational clinical study designed to evaluate
the safety and efficacy of relugolix in over 900 men with
androgen-sensitive advanced prostate cancer who required at least
one year of continuous androgen deprivation therapy. Men were
randomized 2:1 to receive a single loading dose of relugolix 360 mg
followed by relugolix 120 mg once daily, or to treatment with
leuprolide acetate 3-month depot injection, respectively.
Relugolix met the primary efficacy endpoint, with 96.7% of men
treated with relugolix achieving sustained testosterone suppression
to castrate levels (< 50 ng/dL) through 48 weeks versus 88.8% of
men treated with leuprolide acetate. Relugolix also met all six key
secondary endpoints, demonstrating superiority to leuprolide
acetate in rapid and profound suppression of testosterone and PSA
response, in addition to improved testosterone recovery after
discontinuation of treatment. Men in the relugolix group had a 54%
lower risk of major adverse cardiovascular events (MACE) compared
to men in the leuprolide acetate group (2.9% vs. 6.2%,
respectively). In men with a reported history of MACE, the
relugolix group had 80% fewer MACE events reported compared to the
leuprolide acetate group (3.6% vs. 17.8%, respectively). The
overall incidence of adverse events in the relugolix and leuprolide
acetate groups was comparable (92.9% vs. 93.5%, respectively).
Data from an additional key secondary endpoint, castration
resistance-free survival, are expected in the third quarter of
2020.
About Prostate Cancer Prostate cancer is the
second most prevalent form of cancer in men and the second leading
cause of death due to cancer in men in the U.S.
Cardiovascular mortality is the leading cause of death in men with
prostate cancer and accounts for 34% of deaths in men with prostate
cancer in the U.S. More than three million men in the
U.S. are currently living with prostate cancer, and
approximately 190,000 men are estimated to be newly diagnosed in
2020. Advanced prostate cancer is prostate cancer that has spread
or come back after treatment and may include men with biochemical
recurrence (rising PSA in the absence of metastatic
disease on imaging), locally advanced disease, or metastatic
disease. Front-line medical therapy for advanced prostate cancer
typically involves androgen deprivation therapy, which reduces
testosterone to very low levels, commonly referred to as castrate
levels. GnRH receptor agonists, such as leuprolide acetate, are
depot injections and the current standard of care for androgen
deprivation therapy. However, GnRH receptor agonists may be
associated with mechanism-of-action limitations, including the
potentially detrimental initial surge in testosterone levels that
can exacerbate clinical symptoms, which is known as clinical or
hormonal flare, and delayed testosterone recovery after the drug is
discontinued. Approximately 210,000 men are treated with androgen
deprivation therapy with a GnRH agonist or antagonist each
year.
About Relugolix Relugolix is a once-daily, oral
gonadotropin-releasing hormone (GnRH) receptor antagonist that
reduces production of testicular testosterone, a hormone known to
stimulate the growth of prostate cancer, and ovarian estradiol, a
hormone known to stimulate the growth of uterine fibroids and
endometriosis. Myovant is developing relugolix as a
monotherapy tablet (120 mg once daily) for men with advanced
prostate cancer. Myovant is also 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.
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.
About Sumitovant Biopharma
Ltd.
Sumitovant is a global biopharmaceutical company with offices in
New York City and London. Sumitovant is the majority shareholder of
Myovant and Urovant, and wholly owns Enzyvant, Spirovant and
Altavant. Sumitovant's promising pipeline is comprised of
early-through late-stage investigational medicines across a range
of disease areas targeting high unmet need. Sumitovant is a wholly
owned subsidiary of Sumitomo Dainippon Pharma. For further
information about Sumitovant, please visit
https://www.sumitovant.com.
About Sumitomo Dainippon Pharma Co.,
Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed
pharmaceutical companies in Japan, operating globally in major
pharmaceutical markets, including Japan, the U.S., China, and the
European Union. Sumitomo Dainippon Pharma is based on the merger in
2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo
Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more
than 6,000 employees worldwide. Additional information about
Sumitomo Dainippon Pharma is available through its corporate
website at https://www.ds-pharma.com.
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 for men; the FDA’s target action date
of December 20, 2020 under the Prescription Drug User Fee Act
(PDUFA); the FDA’s statement that it is currently not planning to
hold an advisory committee meeting for this application; the
expectation that relugolix would be the first and only oral
gonadotropin-releasing hormone (GnRH) receptor antagonist treatment
for men with advanced prostate cancer; the timing of data from an
additional key secondary endpoint, castration resistance-free
survival, expected in the third quarter of 2020; any expectations
regarding the approval of relugolix in any indication and the
timing of any approval; and any anticipated market size for
relugolix in any indication. 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’ Quarterly 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. 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.
Sumitovant Media Contact:Mary StuttsSVP,
Corporate RelationsSumitovant Biopharma media@sumitovant.com
Myovant Investor Contact: Frank Karbe President
and Chief Financial Officer Myovant Sciences, Inc.
investors@myovant.com
Myovant Media Contact: Albert Liao
Director, Corporate Communications Myovant Sciences, Inc.
media@myovant.com
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