– LINZESS is the first and only FDA-approved
prescription therapy for functional constipation in this patient
population –
– Approval brings a much-needed option to an
estimated 6 million 6-17-year-olds in the U.S.1 affected by this
chronic, prevalent condition –
Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused
healthcare company, today announced that the U.S. Food and Drug
Administration (FDA) has approved LINZESS® (linaclotide) as a
once-daily treatment for pediatric patients ages 6-17 years-old
with functional constipation. LINZESS is the first and only
FDA-approved prescription therapy for functional constipation in
this patient population. Earlier this year, the FDA granted a
6-month priority review to our supplemental New Drug Application
(sNDA), 4 months earlier than the standard review timeline. LINZESS
is developed and marketed by AbbVie and Ironwood Pharmaceuticals in
the United States.
Functional constipation in children is a chronic condition
characterized by hard, infrequent bowel movements that are often
difficult or painful to pass2. The condition affects an estimated 6
million children ages 6-17 years-old in the U.S.1
“When you have a child with functional constipation, it is
extremely hard to watch them suffer – spending hours in the
bathroom and away from their friends – while there is little you
can do as a parent to help them,” said Ceciel T. Rooker, President,
International Foundation for Gastrointestinal Disorders. “There has
long been a critical need for a new therapeutic option due to lack
of approved prescription treatment options, so I’m thrilled that we
now have a new prescription option for children that can
effectively help address symptoms.”
The FDA approval was based on the results of a large,
multicenter, double-blind, Phase III study evaluating LINZESS in
patients ages 6-17 years-old with functional constipation. A total
of 328 patients received the study treatment, randomized in a 1:1
ratio between LINZESS 72 mcg or placebo. In this pivotal study,
linaclotide showed a statistically significant and clinically
meaningful improvement compared to placebo in 12-week spontaneous
bowel movement (SBM) frequency rate (SBMs/week), the primary
endpoint. Linaclotide-treated patients demonstrated a greater than
two-fold least squares mean change from baseline in SBMs/week (2.6)
compared to placebo (1.3) (p<0.0001). The most common adverse
event in the pediatric Phase 3 study was diarrhea, which occurred
in 4% of LINZESS-treated patients versus 2% in the placebo
group.
“Pediatric functional constipation is an all-too-common issue
that physicians see every day, yet despite the tremendous distress
it causes to our patients’ and their families, we haven’t had an
FDA-approved prescription treatment to offer until now,” said
Jeffrey S. Hyams, M.D., Head, Division of Digestive Diseases,
Hepatology, and Nutrition, Connecticut Children’s Medical Center,
Professor of Pediatrics, University of Connecticut School of
Medicine. “The approval of LINZESS for the treatment of functional
constipation in pediatric patients ages 6-17 years-old is a
meaningful advancement for these young patients.”
LINZESS is developed and marketed by Ironwood and AbbVie in the
United States and has been available since 2012 for the treatment
of adults with irritable bowel syndrome with constipation (IBS-C)
or chronic idiopathic constipation (CIC). Linaclotide, the active
ingredient in LINZESS, is a first-in-class guanylate cyclase-C
(GC-C) agonist and acts locally in the intestine with minimal
systemic exposure. Since its launch, it has been used to treat more
than 4.5 million unique adult patients with IBS-C and CIC.
“Today, Ironwood has broken new ground again in the history of
LINZESS, extending the clinical utility of our blockbuster
treatment to 6-17-year-olds seeking relief for functional
constipation, a debilitating condition,” said Tom McCourt, chief
executive officer of Ironwood. “This approval is a momentous step
forward in progressing our mission to advance the treatment of GI
diseases and redefine the standard of care for GI patients and in
ushering in a new era of growth for our company.”
Based on this FDA approval, LINZESS 72mcg is now available for
the treatment of functional constipation for pediatric patients
ages 6-17 years old, with immediate accessibility for most patients
building on the class-leading formulary coverage already in place
for the brand.
About LINZESS (linaclotide)
LINZESS® is the #1 prescribed brand in the U.S. for the
treatment of adult patients with irritable bowel syndrome with
constipation (“IBS-C”) or chronic idiopathic constipation (“CIC”),
based on IQVIA data.
LINZESS is a once-daily capsule that helps relieve the abdominal
pain, constipation, and overall abdominal symptoms of bloating,
discomfort and pain associated with IBS-C, as well as the
constipation, infrequent stools, hard stools, straining, and
incomplete evacuation associated with CIC. LINZESS relieves
constipation in children and adolescents aged 6 to 17 years with
functional constipation. The recommended dose is 290 mcg for IBS-C
patients and 145 mcg for CIC patients, with a 72 mcg dose approved
for use in CIC depending on individual patient presentation or
tolerability. In children with functional constipation aged 6 to 17
years, the recommended dose is 72 mcg.
LINZESS is not a laxative; it is the first medicine approved by
the FDA in a class called GC-C agonists. LINZESS contains a peptide
called linaclotide that activates the GC-C receptor in the
intestine. Activation of GC-C is thought to result in increased
intestinal fluid secretion and accelerated transit and a decrease
in the activity of pain-sensing nerves in the intestine. The
clinical relevance of the effect on pain fibers, which is based on
nonclinical studies, has not been established.
In the United States, Ironwood and AbbVie co-develop and
co-commercialize LINZESS for the treatment of adults with IBS-C or
CIC. In Europe, AbbVie markets linaclotide under the brand name
CONSTELLA® for the treatment of adults with moderate to severe
IBS-C. In Japan, Ironwood's partner, Astellas, markets linaclotide
under the brand name LINZESS for the treatment of adults with IBS-C
or CIC. Ironwood also has partnered with AstraZeneca for
development and commercialization of LINZESS in China, and with
AbbVie for development and commercialization of linaclotide in all
other territories worldwide.
LINZESS Important Safety Information
INDICATIONS AND USAGE
LINZESS® (linaclotide) is indicated for the treatment of both
irritable bowel syndrome with constipation (IBS-C) and chronic
idiopathic constipation (CIC) in adults and functional constipation
(FC) in children and adolescents 6 to 17 years of age. It is not
known if LINZESS is safe and effective in children with FC less
than 6 years of age or in children with IBS-C less than 18 years of
age.
IMPORTANT SAFETY INFORMATION WARNING: RISK OF SERIOUS
DEHYDRATION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE
LINZESS is contraindicated in patients less than 2 years of age;
in nonclinical studies in neonatal mice, administration of a
single, clinically relevant adult oral dose of linaclotide caused
deaths due to dehydration.
CONTRAINDICATIONS
• LINZESS is contraindicated in patients less than 2 years of
age due to the risk of serious dehydration.
• LINZESS is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction.
WARNINGS AND PRECAUTIONS
Risk of Serious Dehydration in Pediatric Patients Less Than 2
Years of Age
LINZESS is contraindicated in patients less than 2 years of age.
In neonatal mice, linaclotide increased fluid secretion as a
consequence of age-dependent elevated guanylate cyclase (GC-C)
agonism, which was associated with increased mortality within the
first 24 hours due to dehydration. There was no age dependent trend
in GC-C intestinal expression in a clinical study of children 2 to
less than 18 years of age; however, there are insufficient data
available on GC-C intestinal expression in children less than 2
years of age to assess the risk of developing diarrhea and its
potentially serious consequences in these patients.
Diarrhea
In adults, diarrhea was the most common adverse reaction in
LINZESS-treated patients in the pooled IBS-C and CIC double-blind
placebo-controlled trials. The incidence of diarrhea was similar in
the IBSC and CIC populations. Severe diarrhea was reported in 2% of
145 mcg and 290 mcg LINZESS-treated patients and in <1% of 72
mcg LINZESS-treated CIC patients.
In children and adolescents 6 to 17 years of age, diarrhea was
the most common adverse reaction in 72 mcg LINZESS-treated patients
in the FC double-blind placebo-controlled trial. Severe diarrhea
was reported in <1% of 72 mcg LINZESS treated patients. If
severe diarrhea occurs, dosing should be suspended and the patient
rehydrated.
Common Adverse Reactions (incidence ≥2% and greater than
placebo)
• In IBS-C or CIC adult patients: diarrhea, abdominal pain,
flatulence, and abdominal distension.
• In FC pediatric patients: diarrhea
http://www.allergan.com/assets/pdf/linzess_pi
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (Nasdaq: IRWD), an S&P SmallCap
600® company, is a leading gastrointestinal (GI) healthcare company
on a mission to advance the treatment of GI diseases and redefine
the standard of care for GI patients. We are pioneers in the
development of LINZESS® (linaclotide), the U.S. branded
prescription market leader for adults with irritable bowel syndrome
with constipation (IBS-C) or chronic idiopathic constipation (CIC).
In June 2023, the U.S. Food and Drug Administration also approved
LINZESS for the treatment of functional constipation in pediatric
patients ages 6-17 years-old. Under the guidance of our seasoned
industry leaders, we continue to build upon our history of GI
innovation and challenge what has been done before to shape what
the future holds. We keep patients at the heart of our R&D and
commercialization efforts to reduce the burden of GI diseases and
address significant unmet needs.
Founded in 1998, Ironwood Pharmaceuticals is headquartered in
Boston, Massachusetts.
We routinely post information that may be important to investors
on our website at www.ironwoodpharma.com. In addition, follow us on
Twitter and on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements.
Investors are cautioned not to place undue reliance on these
forward-looking statements, including statements about Ironwood’s
mission, the size of the pediatric 6-17 years-old population in the
U.S. affected by functional constipation and the therapeutic
benefit to patients suffering from functional constipation. These
forward-looking statements speak only as of the date of this press
release, and Ironwood undertakes no obligation to update these
forward-looking statements. Each forward-looking statement is
subject to risks and uncertainties that could cause actual results
to differ materially from those expressed or implied in such
statement. Applicable risks and uncertainties include those related
to the effectiveness of development and commercialization efforts
by us and our partners; preclinical and clinical development,
manufacturing and formulation development of linaclotide and our
product candidates; the risk that clinical programs and studies may
not progress or develop as anticipated, including that studies are
delayed or discontinued for any reason, such as safety,
tolerability, enrollment, manufacturing, economic or other reasons;
the risk that findings from our completed nonclinical and clinical
studies may not be replicated in later studies; the risk that we or
our partners are unable to obtain, maintain or manufacture
sufficient LINZESS or our product candidates, or otherwise
experience difficulties with respect to supply or manufacturing;
the efficacy, safety and tolerability of linaclotide and our
product candidates; the risk that the therapeutic opportunities for
LINZESS or our product candidates are not as we expect; decisions
by regulatory and judicial authorities; the risk that we may never
get sufficient patent protection for linaclotide and other product
candidates, that patents for linaclotide or other products may not
provide adequate protection from competition, or that we are not
able to successfully protect such patents; developments in the
intellectual property landscape; challenges from and rights of
competitors or potential competitors; the risk that the development
of either our clinical pediatric programs in IBS-C and functional
constipation are not successful or that any of our product
candidates is not successfully commercialized; the risk that our
planned investments do not have the anticipated effect on our
company revenues; the risk that we are unable to manage our
expenses or cash use, or are unable to commercialize our products
as expected; the impact of the COVID-19 pandemic; and the risks
listed under the heading "Risk Factors" and elsewhere in Ironwood's
Annual Report on Form 10-K for the year ended December 31, 2022,
and in our subsequent SEC filings.
1 U.S. Census, 2017 National Population Projection Tables;
Robin, Samantha G. et al, Prevalence of Pediatric Functional
Gastrointestinal Disorders Utilizing the Rome IV Criteria, The
Journal of Pediatrics, December 2017; Koppen, I. J. N. et al.,
Prevalence of Functional Defecation Disorders in Children: A
Systemic Review and Meta-Analysis. J Pediatr. 2018. 2 Di Lorenzo C,
Hyams JS, Saps M, et al. Chapter 16: Childhood Functional
Gastrointestinal Disorders: Child/Adolescent. In: Drossman DA,
Chang L, Chey WD, et al. Rome IV: Functional Gastrointestinal
Disorders: Disorders of Gut-Brain Interaction. Raleigh, NC: Rome
Foundation; 2016.
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version on businesswire.com: https://www.businesswire.com/news/home/20230612173180/en/
Media:
Beth Calitri, 978-417-2031 bcalitri@ironwoodpharma.com
Investors:
Greg Martini, 617-374-5230 gmartini@ironwoodpharma.com
Matt Roache, 617-621-8395 mroache@ironwoodpharma.com
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