NORTH CHICAGO, Ill.,
May 29, 2020 /PRNewswire/
-- AbbVie (NYSE: ABBV), in cooperation with Neurocrine
Biosciences, Inc. (Nasdaq: NBIX), announced that the U.S. Food
and Drug Administration (FDA) approved ORIAHNN™ (elagolix,
estradiol, and norethindrone acetate capsules; elagolix capsules),
with a treatment duration of up to 24
months.2 ORIAHNN is the first FDA-approved
non-surgical, oral medication option for the management of heavy
menstrual bleeding associated with uterine fibroids in
pre-menopausal women.2 ORIAHNN is expected to be
available in the U.S. by the end of June
2020.
"Women who experience heavy menstrual bleeding as a symptom not
only deal with the physical toll of uterine fibroids, but also the
burdens surrounding its management while trying to get through with
their day-to-day routines," said Ayman
Al-Hendy, M.D., Ph.D., investigator for the ELARIS UF-2
clinical trials, and professor of gynecology and director of
translational research at the University of
Illinois at Chicago. "This approval provides women with a
non-surgical option to help address unresolved heavy menstrual
bleeding in an impactful way."
Uterine fibroids, also called leiomyomas, are estrogen and
progesterone-dependent non-cancerous tumors of the uterus and are
the most common type of benign tumor in women of reproductive age,
affecting up to 70 percent of Caucasian women and up to 80 percent
of African American women by age
50.1,3,4,5,6,7 Traditionally, uterine fibroids have
been primarily managed by surgery and are the leading reason for
the hysterectomies performed in the
U.S.1,3,5,8
"It is always deeply rewarding when the years of development our
researchers and scientists dedicate to creating a new way to treat
patients is successful," said Michael
Severino, M.D., vice chairman and president, AbbVie.
"ORIAHNN signifies an important advance in how we can care for
women with uterine fibroids."
In the two, randomized Phase 3 uterine fibroid clinical trials,
ELARIS UF-I and ELARIS UF-II, ORIAHNN achieved the primary endpoint
of clinically meaningful reduction in bleeding (defined as the
proportion of women who achieved both at least a 50 percent
reduction in menstrual blood loss at final month of treatment and a
total menstrual blood loss amount of less than 80 ml), compared
with placebo in final month of study for patients, with seven out
of 10 women no longer experiencing heavy menstrual bleeding versus
one out of 10 women on placebo (P<0.001 for both
trials).9 ORIAHNN also reduced heavy menstrual bleeding
due to uterine fibroids by 50 percent within the first month of
use.9 The results from these studies were recently
published in The New England Journal of Medicine.
ORIAHNN may increase your chances of heart attack, stroke, or
blood clots, especially if you are a smoker over 35 years of age
with high blood pressure.2 Please see the important
safety information below for more information. ORIAHNN is taken
twice daily (morning and evening) at approximately the same time
each day, with or without food. Use of ORIAHNN should be limited to
24 months due to the risk of continued bone loss, which may not be
reversible.2
"We have heard from women with fibroids across the country who
have been hopeful for a treatment with the potential to address
their bleeding effectively," said Jenny
Rosenberg, executive director of CARE About Fibroids. "The
FDA's approval of an oral treatment for women suffering from heavy
menstrual bleeding due to uterine fibroids marks a step forward in
women's health."10
About Uterine Fibroids
Uterine fibroids (also called
leiomyomas or myomas) are non-cancerous, hormonally-responsive
muscle tissue tumors of the
uterus.1,3 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 of African American
women by age 50.1,3,4,5,6,7 Fibroids can range in
size, shape, number and location.5 Fibroids can be
asymptomatic but, in some women, they can cause symptoms such as
heavy menstrual bleeding.3,4,5 Treatment options
for uterine fibroids include surgery (hysterectomy, myomectomy),
endometrial ablation, uterine artery embolization, magnetic
resonance imaging (MRI)-guided focused ultrasound and medical
management with treatments such as oral contraceptives, progestins,
selective progesterone receptor modulators, and
gonadotropin-releasing hormone (GnRH) agonists and
antagonists.1,9
About ORIAHNNTM (elagolix, estradiol, and
norethindrone acetate capsules; elagolix capsules)
ORIAHNN
is approved by the U.S. Food and Drug Administration (FDA) as an
oral medication for the management of heavy menstrual bleeding due
to uterine fibroids in pre-menopausal women.2 ORIAHNN is
an oral combination of elagolix and E2/NETA
(estradiol/norethindrone acetate) to help achieve a balance between
the reduction of heavy bleeding and associated hypoestrogenic side
effects.2
The full U.S. prescribing information, including the medication
guide, for ORIAHNN can be found on rxabbvie.com.
USE
ORIAHNN™ (elagolix, estradiol, and norethindrone acetate
capsules; elagolix capsules) is a prescription medicine used to
control heavy menstrual bleeding related to uterine fibroids in
women before menopause. It should not be taken for more than 24
months. It is not known if ORIAHNN is safe and effective in
children under 18 years of age.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about
ORIAHNN?
ORIAHNN may cause serious side effects,
including:
- Cardiovascular Conditions
-
- ORIAHNN may increase your chances of heart attack, stroke,
or blood clots, especially if you are over 35 years of age and
smoke, have uncontrolled high blood pressure, high cholesterol,
diabetes, or are obese. Stop taking ORIAHNN and call your
healthcare provider right away or go to the nearest hospital
emergency room right away if you have:
-
- Leg pain or swelling that will not go away
- Sudden shortness of breath
- Double vision, bulging of the eyes, or sudden blindness
(partial or complete)
- Pain or pressure in your chest, arm, or jaw
- Sudden, severe headache unlike your usual headaches
- Weakness or numbness in an arm or leg, or trouble speaking
- Bone Loss (Decreased Bone Mineral Density [BMD])
-
- While taking ORIAHNN, your estrogen levels may be low. Low
estrogen levels can lead to BMD loss.
- If you have bone loss on ORIAHNN, your BMD may improve after
you stop taking ORIAHNN, but complete recovery may not occur. It is
unknown if these BMD changes could increase your risk for broken
bones as you age. For this reason, you should not take ORIAHNN
for more than 24 months.
- Your healthcare provider may order an X-ray test called a DXA
scan to check your bone mineral density when you start taking
ORIAHNN and periodically after you start.
- Your doctor may advise you to take vitamin D and calcium
supplements as part of a healthy lifestyle.
- Effects on Pregnancy
-
- Do not take ORIAHNN if you are pregnant or trying to
become pregnant, as it may increase the risk of early pregnancy
loss.
- If you think you may be pregnant, stop taking ORIAHNN
right away and call your HCP.
- ORIAHNN can decrease your menstrual bleeding or result in no
menstrual bleeding at all, making it hard to know if you are
pregnant. Watch for other pregnancy signs like breast tenderness,
weight gain, and nausea.
- ORIAHNN does not prevent pregnancy. You will need to use
effective methods of birth control while taking ORIAHNN and for 1
week after you stop taking ORIAHNN. Examples of effective methods
can include condoms or spermicide, which do not contain
hormones.
- Talk to your HCP about which birth control to use during
treatment with ORIAHNN. Your HCP may change the birth control you
are on before you start taking ORIAHNN.
Do not take ORIAHNN if you:
- Have or have had:
-
- A stroke or heart attack
- A problem that makes your blood clot more than normal
- Blood circulation disorder
- Certain heart valve problems or heart rhythm abnormalities that
can cause blood clots to form in the heart
- Blood clots in your legs (deep vein thrombosis), lungs
(pulmonary embolism), or eyes (retinal thrombosis)
- High blood pressure not well controlled by medicine
- Diabetes with kidney, eye, nerve, or blood vessel damage
- Certain kinds of headaches with numbness, weakness, or changes
in vision, or have migraine headaches with aura if you are over age
35
- Breast cancer or any cancer that is sensitive to female
hormones
- Osteoporosis
- Unexplained vaginal bleeding that has not been diagnosed
- Liver problems including liver disease
- Smoke and are over 35 years old
- Are taking medicines known as strong OATP1B1 inhibitors that
are known or expected to significantly increase the blood levels of
elagolix. Ask your HCP if you are not sure if you are taking this
type of medicine.
- Have had a serious allergic reaction to elagolix, estradiol,
norethindrone acetate, or any of the ingredients in ORIAHNN. Ask
your HCP if you are not sure.
- FD&C Yellow No. 5 (tartrazine) is an ingredient in ORIAHNN,
which may cause an allergic type reaction such as bronchial asthma
in some patients who are also allergic to aspirin.
What should I discuss with my HCP before taking
ORIAHNN?
Tell your HCP about all your medical conditions,
including if you:
- Have or have had:
-
- Broken bones or other conditions that may cause bone
problems
- Depression, mood swings, or suicidal thoughts or behavior
- Yellowing of the skin or eyes (jaundice) or jaundice caused by
pregnancy (cholestasis of pregnancy)
- Are scheduled for surgery. ORIAHNN may increase your risk of
blood clots after surgery. Your doctor may advise you to stop
taking ORIAHNN before you have surgery. If this happens, talk to
your HCP about when to restart ORIAHNN after surgery.
- Are pregnant or think you may be pregnant.
- Are breastfeeding. It is not known if ORIAHNN can pass into
your breastmilk. Talk to your HCP about the best way to feed your
baby if you take ORIAHNN.
Tell your HCP about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal
supplements.
Women on thyroid or cortisol replacement therapy may need
increased doses of the hormone.
Keep a list of your medicines with you to show to your HCP and
pharmacist when you get a new medicine.
What should I avoid while taking ORIAHNN?
- Avoid grapefruit and grapefruit juice during treatment with
ORIAHNN since they may affect the level of ORIAHNN in your blood,
which may increase side effects.
What are the possible side effects of
ORIAHNN?
ORIAHNN can cause additional serious side
effects, including:
- Suicidal thoughts, suicidal behavior, and worsening of
mood. ORIAHNN may cause suicidal thoughts or actions. Call
your HCP or get emergency medical help right away if you have any
of these symptoms, especially if they are new, worse, or bother
you: thoughts about suicide or dying, attempts to commit
suicide, new or worse depression or anxiety, or other unusual
changes in behavior or mood. Pay attention to any changes,
especially sudden changes, in your mood, behaviors, thoughts, or
feelings.
- Abnormal liver tests. Call your HCP right away if you have
any of these signs and symptoms of liver problems: jaundice,
dark amber-colored urine, feeling tired, nausea and vomiting,
generalized swelling, right upper stomach area pain, or bruising
easily.
- High blood pressure. You should see your HCP to check
your blood pressure regularly.
- Gallbladder problems (cholestasis), especially if you
had cholestasis of pregnancy.
- Increases in blood sugar, cholesterol, and fat
(triglyceride) levels.
- Hair loss (alopecia). Hair loss and hair thinning can
happen while taking ORIAHNN, and it can continue even after you
stop taking ORIAHNN. It is not known if this hair loss or hair
thinning is reversible. Talk to your HCP if this is a concern for
you.
- Changes in laboratory tests, including thyroid and other
hormone, cholesterol, and blood clotting tests.
The most common side effects of ORIAHNN include: hot
flashes, headache, fatigue, and irregular periods.
These are not all of the possible side effects of ORIAHNN. Tell
your HCP if you have any side effect that bothers you or that does
not go away. Call your HCP for medical advice about side
effects.
Take ORIAHNN exactly as your HCP tells you. The recommended oral
dosage of ORIAHNN is one yellow/white capsule in the morning and
one blue/white capsule in the evening, with or without food.
This is the most important information to know about ORIAHNN.
For more information, talk to your doctor or HCP.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit
http://www.fda.gov/medwatch or call
1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie
may be able to help. Visit
AbbVie.com/myAbbVieAssist to learn more.
About AbbVie
AbbVie's mission is to discover and
deliver innovative medicines that solve serious health issues today
and address the medical challenges of tomorrow. We strive to have a
remarkable impact on people's lives across several key therapeutic
areas: immunology, oncology, neuroscience, eye care, virology,
women's health and gastroenterology, in addition to products and
services across its Allergan Aesthetics portfolio. For more
information about AbbVie, please visit us at www.abbvie.com.
Follow @abbvie on Twitter, Facebook, Instagram, YouTube and 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, competition from
other products, challenges to intellectual property, 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 2019 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 De La Cruz MS, Buchanan EM. Uterine Fibroids:
Diagnosis and Treatment. Am Fam Physician. 2017 Jan
15;95(2):100-107.
2 ORIAHNN™ (elagolix, estradiol and norethindrone
acetate capsules co-formulated) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
3 Office on Women's Health, WomensHealth.gov.
Uterine Fibroids.
https://www.womenshealth.gov/a-z-topics/uterine-fibroids.
4 Khan A et al. Uterine fibroids: current
perspectives. Int J Women's Health. 2014;6:95-114.
5 The American College of Obstetricians and
Gynecologists: FAQ Uterine
Fibroids. https://www.acog.org/patient-resources/faqs/gynecologic-problems/uterine-fibroids.
6 Wallach EE et al. Uterine myomas: an overview of
development, clinical features, and management. Obstet Gynecol.
2004;104:393–406.
7 Baird DD, Dunson DB, Hill MC, Cousins D,
Schectman JM. High cumulative incidence of uterine leiomyoma in
black and white women: ultrasound evidence. Am J Obstet
Gynecol. 2013;188:100-107.
8 Alternatives to hysterectomy in the management of
leiomyomas. ACOG Practice Bulletin No. 96. American College of
Obstetricians and Gynecologist. Obstet Gynecol 2008;
112:387-400.
9 Data on file.
10 Reference to CARE About Fibroids reflects their
recognition of the need for medical management options for this
patient population, but is not meant to be an endorsement or
recommendation of use by this organization of ORIAHNN or
AbbVie.
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SOURCE AbbVie