− ENTYVIO is Now Available in the U.S. in Both IV and
Subcutaneous Administrations for Maintenance Treatment of Adults
with Moderately to Severely Active Ulcerative Colitis or Crohn’s
Disease
Takeda (TSE:4502/NYSE:TAK) today announced
that the U.S. Food and Drug Administration (FDA) has approved
ENTYVIO® (vedolizumab) subcutaneous (SC) administration for
maintenance therapy in adults with moderately to severely active
Crohn’s disease (CD) after induction therapy with intravenous (IV)
ENTYVIO.1 The subcutaneous administration of ENTYVIO was also
approved by FDA in September 2023 for the maintenance treatment of
adults with moderately to severely active ulcerative colitis (UC)
and is available in the U.S. as a single-dose prefilled pen
(ENTYVIO Pen).*
The approval is based on the VISIBLE 2 Study (SC CD Trial), a
Phase 3, randomized, double-blind, placebo-controlled trial, which
assessed the safety and efficacy of an SC formulation of ENTYVIO as
maintenance therapy in adult patients with moderately to severely
active CD who had clinical response** at Week 6 following two doses
of open-label vedolizumab intravenous therapy at Weeks 0 and 2.1
The primary endpoint was clinical remission*** at Week 52, which
was defined as a total Crohn’s Disease Activity Index (CDAI) score
of ≤150.
“Crohn’s disease is a complex and usually progressive disease
for which an appropriate management plan is critical. My primary
goal as a clinician is always to get patients to achieve remission.
In VISIBLE 2, about half of patients treated with ENTYVIO SC
achieved long-term clinical remission,” said Timothy Ritter, MD,
senior medical director, Department of Research and Education, GI
Alliance Research and assistant professor of medicine, TCU School
of Medicine. “The data from VISIBLE 2 reaffirm the well-established
efficacy profile of ENTYVIO, regardless of route of
administration.”
In VISIBLE 2, a total of 409 patients were randomized at Week 6
in a double-blind fashion (2:1) to ENTYVIO 108 mg administered by
SC injection or placebo every 2 weeks.1 Eligible patients included
patients who had experienced an inadequate response to, loss of
response to, or intolerance to at least one of the following:
corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine,
or methotrexate), or tumor necrosis factor (TNF) blockers
(including primary non-responders).
A statistically significant proportion of patients receiving
ENTYVIO SC 108 mg maintenance therapy administered every 2 weeks
achieved long-term clinical remission*** compared to patients
receiving placebo (48% vs. 34%; p<0.01) at Week 52.1 In clinical
studies, the ENTYVIO SC safety profile was generally consistent
with the known safety profile of ENTYVIO IV, with the addition of
injection site reactions (including injection site erythema, rash,
pruritus, swelling, bruising, hematoma, pain, urticaria and edema)
as an adverse reaction for ENTYVIO SC. The most common adverse
reactions reported with ENTYVIO IV (incidence ≥3% and ≥1% higher
than placebo) were nasopharyngitis, headache, arthralgia, nausea,
pyrexia, upper respiratory tract infection, fatigue, cough,
bronchitis, influenza, back pain, rash, pruritus, sinusitis,
oropharyngeal pain, and pain in extremities.
“The approval of subcutaneous ENTYVIO in Crohn’s disease
delivers on our goal of providing treatment options that can help
patients achieve remission of their ulcerative colitis or Crohn’s
disease, while also providing them flexibility and choice of route
of administration. With ENTYVIO Pen, patients have the option of
administering their maintenance treatment at home or on the go,”
said Brandon Monk, senior vice president, head, U.S.
Gastroenterology Business Unit, Takeda. “Our development of a
subcutaneous option demonstrates Takeda’s commitment to meeting the
very real needs of those living with gastrointestinal
diseases.”
*Please refer to “U.S. FDA Approves Subcutaneous Administration
of Takeda’s ENTYVIO® (vedolizumab) for Maintenance Therapy in
Moderately to Severely Active Ulcerative Colitis”, dated September
27, 2023.
**Clinical response is defined as a ≥70-point decrease in
Crohn’s Disease Activity Index (CDAI) score from baseline (Week
0).1
***Clinical remission is defined as CDAI score of ≤150 at Week
52.1
Takeda does not expect a material impact on the consolidated
financial statements as a result of this approval.
About ENTYVIO (vedolizumab)
Vedolizumab is a biologic therapy and is approved for
intravenous (IV) and subcutaneous (SC) administration (approvals
vary by market).1,2 Vedolizumab SC has been granted marketing
authorization in the United States, European Union and more than 50
countries. Vedolizumab IV has been granted marketing authorization
in more than 70 countries, including the United States and European
Union. Globally, vedolizumab IV and SC have more than one million
patient years of exposure to date.3 Vedolizumab is a humanized
monoclonal antibody designed to specifically antagonize the
alpha4beta7 integrin, inhibiting the binding of alpha4beta7
integrin to intestinal mucosal addressin cell adhesion molecule 1
(MAdCAM-1), but not vascular cell adhesion molecule 1 (VCAM-1).4
MAdCAM-1 is preferentially expressed on blood vessels and lymph
nodes of the gastrointestinal tract.5 The alpha4beta7 integrin is
expressed on a subset of circulating white blood cells.4 These
cells have been shown to play a role in mediating the inflammatory
process in ulcerative colitis and Crohn’s disease.4,6,7 By
inhibiting alpha4beta7 integrin, vedolizumab may limit the ability
of certain white blood cells to infiltrate gut tissues.4
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
ENTYVIO is contraindicated in patients who have had a known
serious or severe hypersensitivity reaction to ENTYVIO or any of
its excipients.
WARNINGS AND PRECAUTIONS
- Infusion-Related and Hypersensitivity Reactions:
Infusion-related reactions and hypersensitivity reactions including
anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and
increased blood pressure and heart rate have been reported. These
reactions may occur with the first or subsequent infusions and may
vary in their time of onset from during infusion or up to several
hours post-infusion. If anaphylaxis or other serious
infusion-related or hypersensitivity reactions occur, discontinue
administration of ENTYVIO immediately and initiate appropriate
treatment.
- Infections: Patients treated with ENTYVIO are at
increased risk for developing infections. Serious infections have
been reported in patients treated with ENTYVIO, including anal
abscess, sepsis (some fatal), tuberculosis, salmonella sepsis,
Listeria meningitis, giardiasis, and cytomegaloviral colitis.
ENTYVIO is not recommended in patients with active, severe
infections until the infections are controlled. Consider
withholding ENTYVIO in patients who develop a severe infection
while on treatment with ENTYVIO. Exercise caution in patients with
a history of recurring severe infections. Consider screening for
tuberculosis (TB) according to the local practice.
- Progressive Multifocal Leukoencephalopathy (PML): PML, a
rare and often fatal opportunistic infection of the central nervous
system (CNS), has been reported with systemic immunosuppressants,
including another integrin receptor antagonist. PML typically only
occurs in patients who are immunocompromised. One case of PML in an
ENTYVIO-treated patient with multiple contributory factors has been
reported. Although unlikely, a risk of PML cannot be ruled out.
Monitor patients for any new or worsening neurological signs or
symptoms that may include progressive weakness on one side of the
body or clumsiness of limbs, disturbance of vision, and changes in
thinking, memory, and orientation leading to confusion and
personality changes. If PML is suspected, withhold dosing with
ENTYVIO and refer to neurologist; if confirmed, discontinue ENTYVIO
dosing permanently.
- Liver Injury: There have been reports of elevations of
transaminase and/or bilirubin in patients receiving ENTYVIO.
ENTYVIO should be discontinued in patients with jaundice or other
evidence of significant liver injury.
- Live and Oral Vaccines: Prior to initiating treatment
with ENTYVIO, all patients should be brought up to date with all
immunizations according to current immunization guidelines.
Patients receiving ENTYVIO may receive non-live vaccines and may
receive live vaccines if the benefits outweigh the risks.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥3% and ≥1% higher
than placebo) were: nasopharyngitis, headache, arthralgia, nausea,
pyrexia, upper respiratory tract infection, fatigue, cough,
bronchitis, influenza, back pain, rash, pruritus, sinusitis,
oropharyngeal pain, pain in extremities, and injection site
reactions with subcutaneous administration.
DRUG INTERACTIONS
Because of the potential for increased risk of PML and other
infections, avoid the concomitant use of ENTYVIO with natalizumab
products and with TNF blockers. Upon initiation or discontinuation
of ENTYVIO in patients treated with CYP450 substrates, monitor drug
concentrations or other therapeutic parameters, and adjust the
dosage of the CYP substrate as needed.
INDICATIONS
Adult Ulcerative Colitis (UC):
ENTYVIO is indicated in adults for the treatment of moderately
to severely active UC.
Adult Crohn’s Disease (CD):
ENTYVIO is indicated in adults for the treatment of moderately
to severely active CD.
DOSAGE FORMS & STRENGTHS:
- ENTYVIO Intravenous (IV) Infusion: 300 mg vedolizumab
- ENTYVIO Subcutaneous (SC) Injection: 108 mg vedolizumab
Please click for Full U.S. Prescribing
Information.
About Ulcerative Colitis and Crohn’s Disease
Ulcerative colitis (UC) and Crohn’s disease (CD) are two of the
most common forms of inflammatory bowel disease (IBD).8 Both UC and
CD are chronic, relapsing, remitting, inflammatory conditions of
the gastrointestinal tract.9,10 UC only involves the large
intestine as opposed to CD, which can affect any part of the GI
tract from mouth to anus.11,12 CD can also affect the entire
thickness of the bowel wall, while UC only involves the innermost
lining of the large intestine.11,12 UC can present with symptoms of
abdominal discomfort or loose bowel movements, including
blood.11,13 CD can present with symptoms of abdominal pain,
diarrhea, and weight loss.12 The cause of UC or CD is not fully
understood; however, research suggests that an interplay between
environmental factors, genetics, and intestinal microbiota may
contribute to the development of UC or CD.11,14,9
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), eosinophilic
esophagitis (EoE), 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.
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Takeda does not undertake to update any of the forward-looking
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Medical Information
This press release contains information about products that may
not be available in all countries, or may be available under
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References
1 ENTYVIO (vedolizumab) Prescribing Information. Takeda
Pharmaceuticals U.S.A., Inc. 2 ENTYVIO Summary of Product
Characteristics (SmPC). Available at:
https://www.ema.europa.eu/en/documents/product-information/entyvio-epar-product-information_en.pdf.
Last updated: April 2023. Last accessed: January 2024. 3 Data on
file. Takeda Pharmaceuticals. 4 Soler D, Chapman T, Yang LL, et al.
J Pharmacol Exp Ther. 2009;330(3):864-875. 5 Briskin M,
Winsor-Hines D, Shyjan A, et al. Am J Pathol. 1997;151:97‑110. 6
Eksteen B, Liaskou E, Adams DH. Inflamm Bowel Dis.
2008;14:1298‑1312. 7 Wyant T, Fedyk E, Abhyankar B. J Crohns
Colitis. 2016;10(12):1437-1444. 8 Baumgart DC, Carding SR. Lancet.
2007;369:1627-1640. 9 Torres J, Mehandru S, Colombel JF,
Peyrin-Biroulet L. Lancet. 2017;389(10080):1741-1755. 10 Krugliak
N, Torres J, Rubin DT. Gastroenterology. 2022;162:1396-1408. 11
Ordas I, Eckmann L, Talamini M, et al. Lancet. 2012;380:1606-1619.
12 Feuerstein JD, Cheifetz AS. Mayo Clin Proc. 2017;92:1088-1103.
13 Sands BE. Gastroenterology. 2004;126:1518-1532. 14 Kobayashi T,
Siegmund B, Le Berre C, et al. Nat Rev Dis Primers. 2020;6(74).
US-VED-2568v1.0 04/24
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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
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