— 12 Weeks of Treatment with EOHILIA May Address
Significant Unmet Needs of Patients 11 Years of Age and
Older
— EoE Is a Chronic Disease That Can Significantly
Impact Patients, with Esophageal Inflammation and Intermittent
Symptoms of Choking and Difficult or Painful Swallowing
Takeda (TSE:4502/NYSE:TAK) today announced
that the U.S. Food and Drug Administration (FDA) has approved
EOHILIA (budesonide oral suspension), the first and only
FDA-approved oral therapy for people 11 years and older with
eosinophilic esophagitis (EoE).1 It will be available in 2 mg/10 mL
convenient, single-dose stick packs by the end of February.
EOHILIA is a corticosteroid indicated for 12 weeks of treatment
in patients 11 years and older with EoE.1 Developed specifically
for EoE, EOHILIA’s novel formulation of budesonide confers
thixotropic properties – flowing more freely when shaken and
returning to a more viscous state when swallowed.1,2
“Various formulations of corticosteroids have been used in the
past to manage EoE, but in an off-label capacity and using multiple
delivery options. With EOHILIA, it’s gratifying to now have an
FDA-approved treatment specifically formulated for a consistent
dose delivery with demonstrated ability to address esophageal
inflammation and EoE dysphagia symptoms,” said Ikuo Hirano, MD,
professor of medicine and director of the Kenneth C. Griffin
Esophageal Center in the Division of Gastroenterology and
Hepatology at Northwestern University Feinberg School of Medicine.
“As the treatment needs and goals of patients with EoE can vary, I
welcome the flexibility that EOHILIA offers as an oral
medication.”
The FDA approval of EOHILIA 2 mg twice daily is based on
efficacy and safety data from two multicenter, randomized,
double-blind, parallel-group, placebo-controlled 12-week studies
(Study 1 and Study 2) in patients (ages 11 to 56 and 11 to 42,
respectively) with EoE.1 In both studies, patients received at
least one dose of either EOHILIA 2 mg twice daily or placebo orally
twice daily. Efficacy endpoints included histologic remission (peak
eosinophil count of ≤6 per high-powered field across all available
esophageal levels) and the absolute change from baseline in
patient-reported Dysphagia Symptom Questionnaire (DSQ) combined
score after 12 weeks of treatment. The DSQ measures how often a
patient with EoE has trouble swallowing and the behavioral
adaptations they subsequently use, as reported directly by
patients.3
Significantly more patients receiving EOHILIA achieved
histologic remission vs. placebo in Study 1 (53.1% vs. 1%).1 In
Study 2, 38% of EOHILIA patients achieved histologic remission vs.
2.4% of those in the placebo group. Absolute change from baseline
in DSQ combined score in the EOHILIA vs. placebo groups in Study 1
was -10.2 (1.5) vs. -6.5 (1.8) and in Study 2, -14.5 (1.8) vs. -5.9
(2.1). During the last two weeks of each study, more patients
receiving EOHILIA experienced no dysphagia or only experienced
dysphagia that “got better or cleared up on its own” as compared to
placebo, as measured by the DSQ. EOHILIA has not been shown to be
safe and effective for the treatment of EoE for longer than 12
weeks. The most common adverse reactions (≥2% of patients receiving
EOHILIA and at a rate greater than placebo) in Study 1 included:
respiratory tract infection (13%), gastrointestinal mucosal
candidiasis (8%), headache (5%), gastroenteritis (3%), throat
irritation (3%), adrenal suppression (2%) and erosive esophagitis
(2%). The safety profile of EOHILIA in Study 2 was generally
similar to Study 1.1
“For most of us, eating is a simple experience. But for people
living with eosinophilic esophagitis, sitting down for a meal can
include painful and difficult swallowing, chest pain and a choking
sensation,” said Brandon Monk, senior vice president and head, U.S.
Gastroenterology Business Unit, Takeda. “With EOHILIA, patients and
their physicians now have the first and only FDA-approved oral
treatment option for EoE that was shown during two 12-week clinical
studies to reduce esophageal inflammation and improve the ability
to swallow.”
EoE is a chronic, immune-mediated, inflammatory disease
localized in the esophagus.4 Although the exact cause is unknown,
it is believed to be triggered by a variety of stimuli including
certain foods and environmental allergens.5,6 The chronic
inflammation of EoE can lead to a range of symptoms, which can vary
by person and age, and include difficulty swallowing, vomiting and
pain.7 Identifying EoE can be complex and delayed diagnosis is
common among patients. If left untreated, the inflammation of EoE
can worsen and narrow the esophagus, which can lead to food
impaction (when food becomes stuck in the esophagus).8,9 In fact,
EoE is the leading cause of emergency room visits for food
impaction.10
Takeda is assessing the financial impacts of the approval,
including a reversal of impairment loss for intangible assets, on
the fiscal year ending on March 31, 2024 (FY2023), but does not
anticipate the impact to be material.
Indication and Limitations of
Use
EOHILIA is indicated for 12 weeks of treatment in adult and
pediatric patients 11 years of age and older with eosinophilic
esophagitis (EoE).
EOHILIA has not been shown to be safe and effective for the
treatment of EoE for longer than 12 weeks.
IMPORTANT SAFETY
INFORMATION
CONTRAINDICATIONS
EOHILIA is contraindicated in patients with hypersensitivity to
budesonide. Serious hypersensitivity reactions, including
anaphylaxis, have occurred with oral budesonide products.
WARNINGS AND PRECAUTIONS
Hypercorticism and Adrenal Axis Suppression
Systemic effects such as hypercorticism and adrenal axis
suppression may occur. Monitor patients for signs and symptoms and
consider reducing the dosage of EOHILIA. Use is not recommended in
patients with severe hepatic impairment (Child‑Pugh Class C) and
monitoring for signs and/or symptoms of hypercorticism is
recommended in patients with moderate hepatic impairment
(Child‑Pugh Class B).
Corticosteroids, including EOHILIA, can reduce the response of
the hypothalamus-pituitary-adrenal (HPA) axis to stress. In
situations where patients are subject to trauma, surgery,
infection, or other stress situations, supplementation with a
systemic corticosteroid is recommended.
Immunosuppression and Increased Risk of Infection
Corticosteroids, including EOHILIA, suppress the immune system
and increase the risk of infection with any pathogen.
Corticosteroid-associated infections can be mild, severe, and at
times fatal. Monitor patients and consider discontinuation of
EOHILIA if the patient develops an infection.
- Tuberculosis reactivation may occur. Closely
monitor patients with latent tuberculosis or tuberculin reactivity
while receiving EOHILIA.
- Varicella Zoster and Measles can be serious or fatal in
non-immune patients taking corticosteroids. Avoid exposure. If a
patient is exposed to varicella, prophylaxis with varicella zoster
immune globulin may be indicated. If varicella develops, treatment
with antiviral agents may be considered. If a patient is exposed to
measles, prophylaxis with immunoglobulin may be indicated.
- Hepatitis B Virus Reactivation can occur. Prior to
starting EOHILIA for patients who show evidence of hepatitis B
infection, recommend consultation with physicians with expertise in
managing hepatitis B regarding monitoring and consideration for
hepatitis B antiviral therapy.
- Amebiasis: It is recommended that latent or active
amebiasis be ruled out before starting EOHILIA in patients who have
spent time in the tropics or have unexplained diarrhea.
- Avoid EOHILIA in patients with: systemic fungal
infections, known or suspected Strongyloides (threadworm)
infection, cerebral malaria, and active ocular herpes simplex.
- Localized Infections: In clinical trials, some patients
developed Candida albicans infections in the mouth, throat, and
esophagus. Instruct patients: do not eat or drink for 30 minutes
after taking EOHILIA; after 30 minutes rinse mouth with water and
spit without swallowing. If oropharyngeal or esophageal candidiasis
develops, treat with appropriate antifungal therapy and consider
discontinuing EOHILIA.
Erosive Esophagitis
Erosive esophagitis occurred in subjects who received EOHILIA in
a 12-week clinical trial. None of the subjects had erosions at
baseline esophagogastroduodenoscopy (EGD), and most were receiving
concomitant therapy with a proton pump inhibitor (PPI). Advise
patients or caregivers to report new onset or worsening signs or
symptoms of erosive esophagitis to their healthcare provider.
Consider endoscopic evaluation as appropriate.
Effect on Growth
Use of corticosteroids may cause a reduction of growth velocity
in pediatric patients. Monitor the growth of pediatric patients on
EOHILIA. The maximum recommended duration of treatment with EOHILIA
is 12 weeks.
Symptoms of Steroid Withdrawal in Patients Transferred from
Other Systemic Corticosteroids
Monitor patients who are transferred from corticosteroids with
high systemic effects to corticosteroids with lower systemic
availability, such as EOHILIA, since symptoms attributed to
withdrawal of steroid therapy, including those of acute adrenal
axis suppression or benign intracranial hypertension, may develop.
Adrenocortical function monitoring may be required in these
patients and the dose of corticosteroid treatment with high
systemic effects should be reduced cautiously. Replacement of
systemic corticosteroids with EOHILIA may unmask allergies (e.g.,
rhinitis and eczema) previously controlled by the systemic
drug.
Other Corticosteroid Effects
Monitor patients with hypertension, diabetes mellitus,
osteoporosis, peptic ulcer, glaucoma, or cataracts, or with family
history of diabetes, glaucoma, or with other conditions where
corticosteroids may have unwanted effects.
Kaposi’s Sarcoma
Kaposi’s sarcoma has been reported to occur in patients
receiving corticosteroid therapy, most often for chronic
conditions. Discontinuation of corticosteroids may result in
clinical improvement of Kaposi’s sarcoma. The maximum recommended
duration of treatment with EOHILIA is 12 weeks.
ADVERSE REACTIONS
Most common adverse reactions (≥2%) are: respiratory tract
infection, gastrointestinal mucosal candidiasis, headache,
gastroenteritis, throat irritation, adrenal suppression, and
erosive esophagitis.
DRUG INTERACTIONS
Budesonide is a substrate for CYP3A4. Avoid concomitant use with
CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir,
indinavir, saquinavir, erythromycin, cyclosporine, and grapefruit
juice), which can increase systemic budesonide concentrations.
USE IN SPECIFIC POPULATIONS
- Pregnancy: Hypoadrenalism may occur in infants born of
mothers receiving corticosteroids during pregnancy. Infants should
be carefully observed for signs of hypoadrenalism and managed
accordingly.
- Lactation: Lactation studies have not been conducted
with EOHILIA. The developmental and health benefits of
breastfeeding should be considered along with the mother’s clinical
need for EOHILIA and any potential adverse effects on the breastfed
infant from EOHILIA, or from the underlying maternal
condition.
- Hepatic Impairment: Not recommended in patients with
severe hepatic impairment (Child-Pugh Class C). In patients with
moderate hepatic impairment (Child-Pugh Class B), monitor for signs
and/or symptoms of hypercorticism.
Please click here for full Prescribing
Information.
Takeda’s Commitment to Gastroenterology
With this latest milestone, Takeda continues to demonstrate a
commitment to meeting the very real needs of those living with
gastrointestinal (GI) diseases. We believe that GI and liver
diseases are life-disrupting conditions. Beyond a fundamental need
for effective treatment options, we understand that improving
patients’ lives also depends on their needs being recognized. With
more than 35 years of experience in gastroenterology, Takeda has
made significant strides in addressing patient needs with
treatments for inflammatory bowel disease (IBD), acid-related
diseases, short bowel syndrome (SBS) and motility disorders. We are
making significant strides toward closing the gap on new areas of
unmet need. Together with researchers, patient groups and more, we
are working to advance scientific research and clinical medicine in
GI.
About Takeda
Takeda is focused on creating better health for people and a
brighter future for the world. We aim to discover and deliver
life-transforming treatments in our core therapeutic and business
areas, including gastrointestinal and inflammation, rare diseases,
plasma-derived therapies, oncology, neuroscience, and vaccines.
Together with our partners, we aim to improve the patient
experience and advance a new frontier of treatment options through
our dynamic and diverse pipeline. As a leading values-based,
R&D-driven biopharmaceutical company headquartered in Japan, we
are guided by our commitment to patients, our people and the
planet. Our employees in approximately 80 countries and regions are
driven by our purpose and are grounded in the values that have
defined us for more than two centuries. For more information, visit
www.takeda.com.
Important Notice
For the purposes of this notice, “press release” means this
document, any oral presentation, any question-and-answer session
and any written or oral material discussed or distributed by Takeda
Pharmaceutical Company Limited (“Takeda”) regarding this release.
This press release (including any oral briefing and any
question-and-answer in connection with it) is not intended to, and
does not constitute, represent or form part of any offer,
invitation or solicitation of any offer to purchase, otherwise
acquire, subscribe for, exchange, sell or otherwise dispose of, any
securities or the solicitation of any vote or approval in any
jurisdiction. No shares or other securities are being offered to
the public by means of this press release. No offering of
securities shall be made in the United States except pursuant to
registration under the U.S. Securities Act of 1933, as amended, or
an exemption therefrom. This press release is being given (together
with any further information which may be provided to the
recipient) on the condition that it is for use by the recipient for
information purposes only (and not for the evaluation of any
investment, acquisition, disposal or any other transaction). Any
failure to comply with these restrictions may constitute a
violation of applicable securities laws.
The companies in which Takeda directly and indirectly owns
investments are separate entities. In this press release, “Takeda”
is sometimes used for convenience where references are made to
Takeda and its subsidiaries in general. Likewise, the words “we”,
“us” and “our” are also used to refer to subsidiaries in general or
to those who work for them. These expressions are also used where
no useful purpose is served by identifying the particular company
or companies.
Forward-Looking Statements
This press release and any materials distributed in connection
with this press release may contain forward-looking statements,
beliefs or opinions regarding Takeda’s future business, future
position and results of operations, including estimates, forecasts,
targets and plans for Takeda. Without limitation, forward-looking
statements often include words such as “targets”, “plans”,
“believes”, “hopes”, “continues”, “expects”, “aims”, “intends”,
“ensures”, “will”, “may”, “should”, “would”, “could”,
“anticipates”, “estimates”, “projects” or similar expressions or
the negative thereof. These forward-looking statements are based on
assumptions about many important factors, including the following,
which could cause actual results to differ materially from those
expressed or implied by the forward-looking statements: the
economic circumstances surrounding Takeda’s global business,
including general economic conditions in Japan and the United
States; competitive pressures and developments; changes to
applicable laws and regulations, including global health care
reforms; challenges inherent in new product development, including
uncertainty of clinical success and decisions of regulatory
authorities and the timing thereof; uncertainty of commercial
success for new and existing products; manufacturing difficulties
or delays; fluctuations in interest and currency exchange rates;
claims or concerns regarding the safety or efficacy of marketed
products or product candidates; the impact of health crises, like
the novel coronavirus pandemic, on Takeda and its customers and
suppliers, including foreign governments in countries in which
Takeda operates, or on other facets of its business; the timing and
impact of post-merger integration efforts with acquired companies;
the ability to divest assets that are not core to Takeda’s
operations and the timing of any such divestment(s); and other
factors identified in Takeda’s most recent Annual Report on Form
20-F and Takeda’s other reports filed with the U.S. Securities and
Exchange Commission, available on Takeda’s website at:
https://www.takeda.com/investors/sec-filings/ or at www.sec.gov.
Takeda does not undertake to update any of the forward-looking
statements contained in this press release or any other
forward-looking statements it may make, except as required by law
or stock exchange rule. Past performance is not an indicator of
future results and the results or statements of Takeda in this
press release may not be indicative of, and are not an estimate,
forecast, guarantee or projection of Takeda’s future results.
Medical Information
This press release contains information about products that may
not be available in all countries, or may be available under
different trademarks, for different indications, in different
dosages, or in different strengths. Nothing contained herein should
be considered a solicitation, promotion or advertisement for any
prescription drugs including the ones under development.
References
1 EOHILIA (budesonide oral suspension) Prescribing Information.
Takeda Pharmaceuticals U.S.A., Inc.
2 Mewis J, Wagner NJ. Advances in Colloid and Interface Science.
2009; 214–227.
3 Hudgens S, Evans C, Phillips E, et al. J Patient Rep Outcomes.
2017;1(1):3.
4 Furuta GT, Katzka DA. N Engl J Med.
2015;373(17):1640-1648.
5 Clayton F, Peterson K. Gastrointest Endosc Clin N Am.
2018;28(1):1-14.
6 O’Shea KM, Aceves SS, Dellon ES, et al. Gastroenterology.
2018;154(2):333-345.
7 Muir AB, Brown-Whitehorn T, Gowin B, et al. Clin Exp
Gastroenterol. 2019;12:391-399.
8 Shaheen NJ, Mukkada V, Eichinger CS, et al. Dis Esophagus.
2018;31(8):1-14.
9 Hirano I, Furuta GT. Gastroenterology.
2020;158(4):840-851.
10 Dellon ES, Hirano I. Gastroenterology.
2018;154(2):319-332.e3.
US-BOS-0537v1.0 02/24
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240209115096/en/
Media: Japanese Media Jun Saito
jun.saito@takeda.com +81 3-3278-2325
U.S. and International Media Amy McCarthy
amy.mccarthy@takeda.com +1 781-496-7761
Takeda Pharmaceutical (NYSE:TAK)
Historical Stock Chart
From Apr 2024 to May 2024
Takeda Pharmaceutical (NYSE:TAK)
Historical Stock Chart
From May 2023 to May 2024