NORTH CHICAGO, Ill.,
Aug. 22, 2018 /PRNewswire/
-- AbbVie (NYSE: ABBV), a research-based global
biopharmaceutical company, in cooperation with Neurocrine
Biosciences, Inc. (NASDAQ: NBIX), announced that results from the
Phase 3 ELARIS UF-EXTEND extension study (MI2-816) showed at month
12 that elagolix (300 mg twice daily), in combination with low-dose
hormone (add-back) therapy (estradiol 1.0 mg / norethindrone
acetate 0.5 mg), reduced heavy menstrual bleeding with 87.9 percent
of women with uterine fibroids achieving clinical response.
This result is consistent with that observed in the two pivotal
Phase 3 studies, ELARIS UF-I and ELARIS UF-II, in which 68.5
percent and 76.2 percent of women with uterine fibroids who
received elagolix with add-back therapy for six months achieved
clinical response, respectively. Clinical response was defined as
menstrual blood loss volume of less than 80 mL and a 50 percent or
greater reduction in menstrual blood loss volume from baseline to
their final month. Secondary endpoint results in the extension
study were also consistent with that observed in the pivotal
studies.1
Uterine fibroids are the most common type of benign abnormal
growth in a woman's pelvis.2 Most American women will
develop fibroids at some point in their lives.2,5
Fibroids can be asymptomatic, but in approximately 25 percent of
women,3 they can cause symptoms, such as heavy menstrual
bleeding, painful periods, vaginal bleeding at times other than
menstruation, and anemia.2 African American women are
more likely to experience fibroids and do so at a younger
age.4
"Women with uterine fibroids are in need of additional medical
management options that could help address unresolved symptoms,"
said Dawn Carlson, M.D., M.P.H.,
vice president, general medicine development. "The results from
this extension study provide additional information on the use of
elagolix for up to 12 months in the management of heavy menstrual
bleeding associated with uterine fibroids."
The safety profile in ELARIS UF-EXTEND was consistent with
previously reported topline results from the pivotal Phase 3
studies and no new safety signals were identified. The most
frequent adverse events reported (≥ 5 percent) were hot flush,
night sweats, nausea, headache and nasopharyngitis. Reduction of
bone mineral density (BMD) was also observed. Evaluation of BMD at
12 months showed women with heavy menstrual bleeding associated
with uterine fibroids who received elagolix in combination
with add-back therapy had less mean percent change from baseline in
BMD compared to women who received elagolix alone.1
Safety data will continue to be collected and analyzed.
Data from the pivotal Phase 3 studies will be presented at a
medical conference later this year and the ELARIS UF-EXTEND Phase 3
study data will be presented at a future medical conference.
Data from the Phase 3 program will support regulatory submission
for elagolix in uterine fibroids, anticipated in 2019.
Elagolix in uterine fibroids is investigational and has not been
proven safe and effective.
Overview of the Elagolix Phase 3 Uterine Fibroids
Program
The elagolix Phase 3 uterine fibroid program evaluated nearly
800 premenopausal women with heavy menstrual bleeding associated
with uterine fibroids in two pivotal studies at approximately 100
sites in the United States and
Canada. The replicate studies evaluated the safety,
tolerability and efficacy of elagolix alone (300 mg twice daily or
BID) and in combination with low-dose hormone (add-back) therapy
(estradiol 1.0 mg / norethindrone acetate 0.5 mg) in women with
uterine fibroids for six months. The primary endpoint assessed the
reduction in heavy menstrual bleeding compared to placebo as
measured by the alkaline hematin method, an objective measurement
of total menstrual blood loss based on quantitation of menstrual
blood collected on sanitary products.
ELARIS UF-EXTEND is a Phase 3 randomized, double-blind,
multicenter, extension study designed to evaluate the efficacy and
safety of elagolix alone and in combination with add-back therapy
in premenopausal women with heavy menstrual bleeding associated
with uterine fibroids for an additional six months (up to 12 months
total). Subjects who received elagolix 300 mg twice daily or
elagolix 300 mg twice daily in combination with add-back therapy in
the pivotal studies continued to receive the same treatment while
subjects who received placebo in the pivotal studies were
randomized in an equal ratio to one of the two treatment groups
(elagolix 300 mg twice daily or elagolix 300 mg twice daily in
combination with add-back therapy).
An overview of the results from the elagolix Phase 3 uterine
fibroids program is below.1
Primary Endpoint
Results at Final Month Across the Elagolix Phase 3
Uterine Fibroids Program
|
Study
|
Responder
Rate
|
Elagolix 300 mg
BID + Add-Back Therapy
|
PBO
|
ELARIS
UF-I
|
68.5%
(p<0.001)
n=206
|
8.7%
n=102
|
ELARIS
UF-II
|
76.2%
(p<0.001)
n=189
|
10.1%
n=94
|
ELARIS
UF-EXTEND
|
87.9%
n=206
|
N/A
|
About Uterine Fibroids
Uterine fibroids (also called leiomyomas or myomas) are
non-cancerous, hormonally-responsive muscle tissue tumors of the
uterus.3 Fibroids are the most common
type of abnormal growth in a woman's pelvis and can affect up to 70
percent of Caucasian women and up to 80 percent of African American
women by age 50.2,5 Fibroids can range in
size, shape, number and location.2 Fibroids can be
asymptomatic, but in some women, fibroids can cause symptoms such
as heavy menstrual bleeding, painful periods, vaginal bleeding at
times other than menstruation, anemia, pain in the abdomen or lower
back, pain during sex, difficulty urinating or frequent urination,
constipation, rectal pain or difficulty getting
pregnant.2 Treatment options for uterine
fibroids include surgery (hysterectomy, myomectomy), hysteroscopy,
endometrial ablation, uterine artery embolization, magnetic
resonance imaging-guided ultrasound and medical management with
treatments such as oral contraceptives, progestins, selective
progesterone receptor modulators, and GnRH agonists.2
Fibroids are the leading indication for hysterectomy in
the United States.5
About Elagolix
Elagolix is an orally-administered, nonpeptide, small molecule
gonadotropin-releasing hormone (GnRH) receptor antagonist that
inhibits endogenous GnRH signaling by binding competitively to GnRH
receptors in the pituitary gland.6 Administration
results in dose-dependent suppression of luteinizing hormone (LH)
and follicle-stimulating hormone (FSH), leading to decreased blood
concentrations of ovarian sex hormones, estradiol and
progesterone.6 Elagolix is currently being investigated
in diseases that are mediated by ovarian sex hormones, such as
uterine fibroids and endometriosis. To date, elagolix has been
studied in over 40 clinical studies, totaling more than 3,700
subjects. U.S. regulatory submission for elagolix in uterine
fibroids is anticipated in 2019.
About ORILISSATM (elagolix)
ORILISSA is approved by the U.S. Food and Drug Administration
(FDA) for the management of moderate to severe pain associated with
endometriosis. The recommended duration of use for ORILISSA is up
to 24 months for the 150 mg once daily dose and up to six months
for the 200 mg twice daily dose, as it causes a dose-dependent
decrease in bone mineral density (BMD). BMD loss is greater
with increasing duration of use and may not be completely
reversible after stopping treatment. For women with moderate
hepatic impairment, the recommended dosage is 150 mg once daily for
up to six months. ORILISSA is recommended to be taken orally at
approximately the same time each day, with or without
food.6
Please click here for full Prescribing Information, including
the Medication Guide.
USE:
ORILISSA is a prescription medicine used to treat
moderate to severe pain associated with endometriosis. It is not
known if ORILISSA is safe and effective in children under 18 years
of age.
IMPORTANT SAFETY INFORMATION:
What is the most
important information I should know about ORILISSA?
Take
ORILISSA exactly as your healthcare provider tells you.
ORILISSA may cause serious side effects, including:
- Bone Loss (decreased Bone Mineral Density (BMD))
While you are taking ORILISSA, your estrogen levels will be low.
This can lead to BMD loss. Your BMD may improve after stopping
ORILISSA but may not recover completely. It is unknown if these
bone changes could increase your risk for broken bones as you age.
Your healthcare provider may order a DXA scan to check your
BMD.
- Effects on Pregnancy
Do not take ORILISSA if
you are trying to become or are pregnant as your risk for early
pregnancy loss may increase. If you think you are pregnant,
stop taking ORILISSA right away and call your healthcare provider.
ORILISSA may change your menstrual periods (irregular bleeding or
spotting, a decrease in menstrual bleeding, or no bleeding at all),
making it hard to know if you are pregnant. Watch for other
signs of pregnancy such as breast tenderness, weight gain and
nausea. ORILISSA does not prevent pregnancy. You will need to
use effective hormone-free birth control (such as condoms or
spermicide) while taking ORILISSA and for one week after stopping
ORILISSA. Birth control pills that contain estrogen may make
ORILISSA less effective. It is unknown how well ORILISSA
works while on progestin-only birth control.
Do not take ORILISSA if you:
- are or may be pregnant, have osteoporosis, have severe liver
disease, or take medicines known as strong OATP1B1 inhibitors such
as cyclosporine or gemfibrozil. If you are unsure if you are taking
one of these medicines, ask your healthcare provider.
What should I tell my healthcare provider before taking
ORILISSA?
Tell your healthcare provider of all
your medical conditions, including if you:
- have or have had broken bones, have other conditions or take
medicine that may cause bone problems, have or have had depression,
mood problems or suicidal thoughts or behavior, have liver
problems, think you may be pregnant, or are breastfeeding or plan
to be. It is unknown if ORILISSA passes into breastmilk. Talk to
your healthcare provider about the best way to feed your baby if
you take ORILISSA.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements. Especially tell your
healthcare provider if you take birth control pills. Your
healthcare provider may advise you to change the pills you take or
your method of birth control.
What are the possible side effects of
ORILISSA?
ORILISSA can cause serious side
effects including:
- suicidal thoughts, actions, or behavior, and worsening
mood. Call your healthcare provider right away, or call 911 if
an emergency, if you have any of these symptoms, especially if they
are new, worse, or bother you: thoughts about suicide or dying, try
to commit suicide, new or worse depression or anxiety, or other
unusual changes in behavior or mood. You or your caregiver should
pay attention to any changes, especially sudden changes in your
mood, behaviors, thoughts, or feelings.
- abnormal liver tests. Call your healthcare provider
right away if you have any of these signs and symptoms of liver
problems: yellowing of the skin or the whites of the eyes
(jaundice), dark amber-colored urine, feeling tired, nausea and
vomiting, generalized swelling, right upper stomach area pain,
bruising easily.
The most common side effects of ORILISSA include: hot
flashes or night sweats, headache, nausea, difficulty sleeping,
absence of periods, anxiety, joint pain, depression and mood
changes.
These are not all the possible side effects of ORILISSA. This is
the most important information to know about ORILISSA. For
more information, talk to your healthcare provider.
Tell your healthcare provider if you have any side effect that
bothers you or that does not go away. Call your healthcare
provider for medical advice about side effects.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
If you cannot afford your medication, contact www.pparx.org for
assistance.
About AbbVie
AbbVie is a global, research and development-based
biopharmaceutical company committed to developing innovative
advanced therapies for some of the world's most complex and
critical conditions. The company's mission is to use its expertise,
dedicated people and unique approach to innovation to markedly
improve treatments across four primary therapeutic areas:
immunology, oncology, virology and neuroscience. In more than
75 countries, AbbVie employees are working every day to advance
health solutions for people around the world. For more information
about AbbVie, please visit us at www.abbvie.com. Follow @AbbVieUS
on Twitter, Facebook or LinkedIn.
Forward-Looking Statements
Some statements in this news release are, or may be considered,
forward-looking statements for purposes of the Private Securities
Litigation Reform Act of 1995. The words "believe," "expect,"
"anticipate," "project" and similar expressions, among others,
generally identify forward-looking statements. AbbVie cautions that
these forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially
from those indicated in the forward-looking statements. Such risks
and uncertainties include, but are not limited to, challenges to
intellectual property, competition from other products,
difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry. Additional information
about the economic, competitive, governmental, technological and
other factors that may affect AbbVie's operations is set forth in
Item 1A, "Risk Factors," of AbbVie's 2017 Annual Report on Form
10-K, which has been filed with the Securities and Exchange
Commission. AbbVie undertakes no obligation to release publicly any
revisions to forward-looking statements as a result of subsequent
events or developments, except as required by law.
_______________________________________
1 Data on File, ABVRRTI66805
2 National Women's Health Network: Uterine Fibroids.
https://www.nwhn.org/uterine-fibroids/. Accessed March 31, 2017.
3 Borah BJ, Nicholson WK, Bradley L, Stewart EA. The
impact of uterine leiomyomas: a national survey of affected women.
Am J Obstet Gynecol. 2013;209(4): 319.e1–319.e20
4 The American College of Obstetricians and
Gynecologists: FAQ Uterine Fibroids.
http://www.acog.org/-/media/For-Patients/faq074.pdf?dmc=1&ts=20170329T1658263942.
Accessed March 31, 2017.
5 Baird, D. D., Dunson, D. B., Hill, M. C., Cousins, D.
& Schectman, J. M. High cumulative incidence of uterine
leiomyoma in black and white women: Ultrasound evidence. Am. J.
Obstet. Gynecol. 2013; 188, 100–107
6 Orilissa (elagolix) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
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SOURCE AbbVie