- The New Drug Application (NDA) includes data from the Phase III
studies OASIS 1, 2 and 3 - showing elinzanetant significantly
reduced the frequency and severity of moderate to severe vasomotor
symptoms (VMS, also known as hot flashes) over 12 weeks compared to
placebo
- 80% of U.S. women will experience hot flashes during the
menopause transition with many remaining untreated1
- Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and
NK-3) receptor antagonist in late-stage clinical development for
the non-hormonal treatment of moderate to severe VMS associated
with menopause
Bayer today announced that a New Drug Application (NDA) for the
investigational compound elinzanetant has been submitted to the
U.S. Food and Drug Administration (FDA) for the treatment of
moderate to severe vasomotor symptoms (VMS, also known as hot
flashes) associated with menopause. The submission is based on the
positive results from the Phase III OASIS 1, 2 and 3 studies.
“Half of the world’s population will experience menopause, with
27 million women in the U.S. currently experiencing this
transition. Despite the impact menopausal symptoms may have on
women’s health and quality of life, many go without treatment due
to gaps in awareness, education, and limitations of treatment
options available,” said Christine Roth, Executive Vice President,
Global Product Strategy and Commercialization, Member of the
Pharmaceutical Leadership Team at Bayer. “The FDA submission for
elinzanetant marks a significant milestone in our efforts to offer
a new non-hormonal option for women. This further underscores our
position as leaders in Women's Health and our dedication to
addressing the unmet medical needs of women globally.”
The submission is based on positive results from the OASIS 1, 2
and 3 Phase III studies evaluating the efficacy and safety of the
investigational compound elinzanetant versus placebo. Findings
showed that elinzanetant (120 mg orally once daily) significantly
reduced the frequency and severity of moderate-to-severe VMS and
demonstrated a favorable safety profile with headache and fatigue
being the most frequent treatment emergent adverse events (TEAEs)
within the elinzanetant groups. Consistent improvements were also
seen across OASIS 1 and 2 in all three key secondary endpoints,
with significant reduction in frequency of VMS at week 1,
improvement in sleep disturbances and menopause-related quality of
life.
The full results of OASIS 1 and 2 were recently presented at the
2024 American College of Obstetricians and Gynecologists (ACOG)
Annual Clinical & Scientific Meeting. Positive topline results
for the Phase III study OASIS 3 were announced in March 2024,
providing additional supporting efficacy data as well as safety
data of elinzanetant over 52 weeks, with details being presented at
an upcoming scientific meeting.
Hot flashes are among the most frequently reported symptoms of
menopause, a transitional phase in a woman’s life expected to
affect 1.2 billion women worldwide by 2030.2 Hot flashes have also
been shown to negatively impact women’s quality of life and are one
of the leading causes for women to seek medical attention.1,3 It is
important that additional options become available to give women a
choice on how to address these symptoms.
Bayer will submit applications for marketing authorizations of
elinzanetant for the treatment of moderate to severe VMS associated
with menopause to other health authorities as well.
About the OASIS 1, 2 and 3 studies OASIS 1 and 2 are
double-blind, randomized, placebo-controlled multicenter studies
investigating the efficacy and safety of elinzanetant administered
orally once daily in women with moderate-to-severe VMS associated
with menopause over 26 weeks. OASIS 1 and 2 randomized 396 and 400
postmenopausal women between 40 and 65 years across 184 sites in 15
countries. OASIS 3 is a double-blind, randomized,
placebo-controlled multicenter study to investigate the efficacy
and safety of elinzanetant for the treatment of vasomotor symptoms
over 52 weeks in postmenopausal women. OASIS 3 randomized 628
postmenopausal women between 40 and 65 years across 83 sites in 9
countries.
About the Elinzanetant clinical development program The
Phase III clinical development program of elinzanetant, OASIS,
currently comprises four Phase III studies: OASIS 1, 2, 3 and 4.
The OASIS 1, 2 and 3 studies investigate the efficacy and safety of
elinzanetant 120 mg in women with moderate to severe VMS associated
with menopause. The OASIS 4 study is an expansion of the clinical
Phase III program and investigates the efficacy and safety of
elinzanetant in women with moderate to severe VMS caused by
endocrine therapy for treatment or prevention of breast cancer.
The design and dosing of the Phase III clinical development
program is based on the positive data from two Phase II studies
(RELENT-1 and SWITCH-1). RELENT-1 was a Phase Ib/IIa study
investigating the safety, pharmacokinetics and preliminary efficacy
of elinzanetant. SWITCH-1 was a Phase IIb study investigating the
efficacy and safety of four different doses of elinzanetant
compared to placebo in women with VMS.
In addition to the OASIS program, Bayer is conducting NIRVANA
(NCT06112756), an exploratory Phase II randomized, parallel-group
treatment, double-blind study. The primary objective is to explore
the efficacy of elinzanetant on sleep disturbances associated with
menopause as determined by polysomnography (PSG). PSG is a
validated method to study sleep and underlying causes of sleep
disturbances. Additional objectives include exploring the efficacy
of elinzanetant on SDM as determined by patient-reported outcomes
and further evaluating the safety of elinzanetant.
About Elinzanetant Elinzanetant is the first dual
neurokinin-1 and 3 (NK-1 and 3) receptor antagonist, in late-stage
clinical development for the non-hormonal treatment of
moderate-to-severe VMS associated with menopause, administered
orally once daily. Elinzanetant may address moderate-to-severe VMS
by modulating a group of estrogen sensitive neurons in the
hypothalamus region of the brain (the KNDy neurons) which, with the
decrease of estrogen, become hypertrophic and lead to a
hyperactivation of the thermoregulatory pathway, consequently
disrupting body heat control mechanisms resulting in VMS.
Elinzanetant may also decrease sleep disturbances associated with
menopause.
About Vasomotor Symptoms Vasomotor symptoms (VMS; also
referred to as hot flashes) result from hyperactivation of the
thermoregulatory pathway mediated by hypertrophy of the KNDy
neurons. This is due to a decrease of estrogen, which can result
from the progressive reduction of ovarian function due to natural
menopause or medical intervention by bilateral oophorectomy or
endocrine therapy.
Based on results from a large and diverse longitudinal study of
menopausal transition in the US, VMS are reported by up to 80% of
women at some point during the menopausal transition and are one of
the leading causes for seeking medical attention during this phase
of a woman’s life. Over one-third of menopausal women report severe
symptoms, which can last 10 years or more after the last menstrual
period, with relevant impact on quality of life.
VMS may also be caused by endocrine therapy, for the treatment
or prevention of breast cancer, impacting quality of life and
treatment adherence. For these women, there are currently no
approved treatment options.
About Menopause By 2030, the global population of women
experiencing menopause is projected to increase to 1.2 billion,
with 47 million women entering this phase each year. Menopause is a
transitional phase in women’s lives, related to the progressive
decline of ovarian function. It usually occurs in women during
their 40s or early 50s. It can also be the result of surgical or
medical treatment such as breast cancer treatment. The hormonal
decline can lead to various symptoms which can substantially affect
a woman’s health, quality of life, healthcare utilization and work
productivity. The most frequently reported and disruptive symptoms
during the menopausal transition are VMS, sleep disturbances and
mood changes. Addressing these symptoms is key to maintaining
functional ability and quality of life in menopause which is highly
relevant from both a healthcare and socio-economic perspective.
About Women’s Healthcare at Bayer Women’s Health is in
Bayer’s DNA. As a global leader in women’s healthcare Bayer has a
long-standing commitment to delivering science for a better life by
advancing a portfolio of innovative treatments. Bayer offers a wide
range of effective short- and long-acting birth control methods as
well as therapies for menopause management and gynecological
diseases. Bayer is also focusing on innovative options to address
the unmet medical needs of women worldwide and to broadening
treatment choices such as in menopause. Additionally, Bayer intends
to provide 100 million women per year in low-and-middle income
countries by 2030 with access to family planning by funding
multi-stakeholder aid programs for capacity building and by
ensuring the supply of affordable modern contraceptives. This is
part of the comprehensive sustainability measures and commitments
from 2020 onwards and in line with the Sustainable Development
Goals of the United Nations.
About Bayer Bayer is a global enterprise with core
competencies in the life science fields of health care and
nutrition. In line with its mission, “Health for all, Hunger for
none,” the company’s products and services are designed to help
people and the planet thrive by supporting efforts to master the
major challenges presented by a growing and aging global
population. Bayer is committed to driving sustainable development
and generating a positive impact with its businesses. At the same
time, the Group aims to increase its earning power and create value
through innovation and growth. The Bayer brand stands for trust,
reliability and quality throughout the world. In fiscal 2023, the
Group employed around 100,000 people and had sales of 47.6 billion
euros. R&D expenses before special items amounted to 5.8
billion euros. For more information, go to www.bayer.com.
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Bayer | Pharmaceuticals
ko (2024-0108E)
Forward-Looking Statements This release may contain
forward-looking statements based on current assumptions and
forecasts made by Bayer management. Various known and unknown
risks, uncertainties and other factors could lead to material
differences between the actual future results, financial situation,
development or performance of the company and the estimates given
here. These factors include those discussed in Bayer’s public
reports which are available on the Bayer website at www.bayer.com.
The company assumes no liability whatsoever to update these
forward-looking statements or to conform them to future events or
developments.
1 Thurston RC, Joffe H. Obstet Gynecol Clin North Am. 2011
Sep;38(3): 489–501 2 Hill, Maturitas 1996 Mar;23(2):113-27. 3
Biglia N, et al. ecancer2019;13:909.
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