Myovant Sciences (NYSE: MYOV), a healthcare company focused on
redefining care for women and for men, today announced that its New
Drug Application (NDA) for once-daily, oral relugolix (120 mg) for
the treatment of men with advanced prostate cancer has been
accepted for Priority Review by the U.S. Food and Drug
Administration (FDA).
“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 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.
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.
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 Feb 2024 to Mar 2024
Myovant Sciences (NYSE:MYOV)
Historical Stock Chart
From Mar 2023 to Mar 2024