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Takeda Receives Positive CHMP Opinion for Vedolizumab IV for the Treatment of Active Chronic Pouchitis

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Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of intravenous (IV) vedolizumab for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC), and have had an inadequate response with or lost response to antibiotic therapy. The CHMP opinion will now be reviewed by the European Commission. If approved, vedolizumab will become the first treatment indicated for active chronic pouchitis across the European Union.

Pouchitis is a major complication after proctocolectomy with IPAA in UC patients.3 Although acute pouchitis may respond to antibiotic therapy, antibiotic-refractory pouchitis, where the condition does not adequately respond to antibiotic therapy, can result in frequent relapses.4 Antibiotic-refractory pouchitis affects 10-15% of patients with pouchitis globally, and can have a considerable impact on their quality of life.5,6,7

“Takeda has made significant strides in advancing the treatment and care of patients with gastrointestinal diseases and we welcome today’s positive opinion for vedolizumab in pouchitis” said Chinwe Ukomadu, head, GI Therapeutic Area Unit, Takeda. “Pouchitis can be a long-term, debilitating disease that has a large impact on the quality of life of patients. We are pleased to bring a new non-surgical treatment option to patients in Europe for whom there is currently no specific approved therapy and we will continue to investigate the use of vedolizumab for this and other such indications where there is an unmet need.”

The positive opinion from the CHMP was based on the EARNEST trial, recently presented at the United European Gastroenterology’s annual meeting, UEG Week Virtual 2021, which assessed the safety and efficacy of vedolizumab IV in the treatment of active chronic pouchitis.8,9 Moreover, information from a number of retrospective studies of historical data indicating that vedolizumab can have a positive impact on patients with inflammation of the pouch was also included in the application.5,6,7,10,11,12

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About Pouchitis
Patients with ulcerative colitis (UC) may require removal of their colon and rectum (proctocolectomy), and the surgical creation of an ileal pouch to aid stool retention (ileal pouch-anal anastomosis or IPAA). Pouchitis, where inflammation and irritation are seen in the lining of the new pouch, is the most common complication of an IPAA, affecting approximately 50% of patients.4 Acute pouchitis may respond to antibiotic therapy, however there are currently no approved therapies indicated for active chronic pouchitis in the European Union, including the refractory form of pouchitis, which does not respond to antibiotic therapy, and where patients frequently relapse.4 Refractory pouchitis affects 10-15% of patients with pouchitis, and can have a considerable impact on their quality of life, causing fecal urgency, incontinence, straining during defecation, bleeding, abdominal or pelvic discomfort, fever and malaise.1,5,6,7

The prevalence of all pouchitis has been calculated to be 12 to 18 patients per 100,000 in Western countries.13

About the EARNEST clinical trial
EARNEST is a randomized, double-blind, placebo-controlled multicenter study that evaluated the efficacy and safety of vedolizumab IV in the treatment of 102 adult patients with UC who had undergone a proctocolectomy and IPAA, and had developed active chronic pouchitis, defined as patients who had inadequate response with or lost response to antibiotics therapy. The EARNEST study met its primary endpoint of clinical remission at week 14. Measured using the modified Pouchitis Disease Activity Index (mPDAI), clinical remission rates were 31.4% (95% CI: 19.1% – 45.9%) in patients in the vedolizumab IV arm (n=51), compared with 9.8% (95% CI: 3.3% – 21.4%) in the placebo arm (n=51). Safety findings were in line with general use of vedolizumab. Adverse events (AEs) were reported in 47 (92.2%) and 44 (86.3%) of patients treated with vedolizumab and placebo, respectively. Treatment-related AEs (as assessed by the investigator) were reported in 12 (23.5%) and 11 (21.6%) of patients treated with vedolizumab and placebo, respectively. Serious AEs were reported in 3 (5.9%) and 4 (7.8%) patients treated with vedolizumab and placebo, respectively.8

The EARNEST study was presented at the annual meeting of the United European Gastroenterology, UEG Week Virtual 2021.9

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).14 Both UC and CD are chronic, relapsing, remitting, inflammatory conditions of the gastrointestinal tract, with CD potentially progressing over time.15,16 UC only involves the large intestine as opposed to CD which can affect any part of the GI tract from mouth to anus.17,18 CD can also affect the entire thickness of the bowel wall while UC only involves the innermost lining of the large intestine.17,18 UC commonly presents with symptoms of abdominal discomfort, loose bowel movements, including blood or pus.17,19 CD commonly presents with symptoms of abdominal pain, diarrhea, and weight loss.15 The cause of UC or CD is not fully understood; however, recent research suggests hereditary, genetics, environmental factors, and/or an abnormal immune response to microbial antigens in genetically predisposed individuals can lead to UC or CD.17,20,21

About Entyvio® (vedolizumab)
Vedolizumab is a gut-selective biologic and is approved in both intravenous (IV) and subcutaneous (SC) formulations.2,22 The SC formulation is currently approved in Europe, Canada, Australia, and Switzerland only. It 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).23 MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract.24 The alpha4beta7 integrin is expressed on a subset of circulating white blood cells.23 These cells have been shown to play a role in mediating the inflammatory process in ulcerative colitis (UC) and Crohn’s disease (CD).23,25,26 By inhibiting alpha4beta7 integrin, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues.23

Vedolizumab is approved for the treatment of adult patients with moderately to severely active UC and CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα)-antagonist.2,22 Vedolizumab has been granted marketing authorization in over 70 countries, including the United States and European Union, with more than 740,000 patient years of exposure to date.27

Therapeutic Indications for vedolizumab

Ulcerative colitis
Vedolizumab is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist.

Crohn’s disease
Vedolizumab is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist.

Important Safety Information for vedolizumab

Contraindications
Hypersensitivity to the active substance or to any of the excipients.

Special warnings and special precautions for use
Intravenous vedolizumab should be administered by a healthcare professional prepared to manage hypersensitivity reactions, including anaphylaxis, if they occur. Appropriate monitoring and medical support measures should be available for immediate use when administering intravenous vedolizumab. Observe patients during infusion and until the infusion is complete.

Infusion-related reactions and Hypersensitivity Reactions
In clinical studies, infusion-related reactions (IRR) and hypersensitivity reactions have been reported, with the majority being mild to moderate in severity. If a severe IRR, anaphylactic reaction, or other severe reaction occurs, administration of vedolizumab must be discontinued immediately and appropriate treatment initiated (e.g., epinephrine and antihistamines). If a mild to moderate IRR occurs, the infusion rate can be slowed or interrupted and appropriate treatment initiated (e.g., epinephrine and antihistamines). Once the mild or moderate IRR subsides, continue the infusion. Physicians should consider pre-treatment (e.g., with antihistamine, hydrocortisone and/or paracetamol) prior to the next infusion for patients with a history of mild to moderate IRR to vedolizumab, in order to minimize their risks.

Infections
Vedolizumab is a gut-selective integrin antagonist with no identified systemic immunosuppressive activity. Physicians should be aware of the potential increased risk of opportunistic infections or infections for which the gut is a defensive barrier. Vedolizumab treatment is not to be initiated in patients with active, severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections until the infections are controlled, and physicians should consider withholding treatment in patients who develop a severe infection while on chronic treatment with vedolizumab. Caution should be exercised when considering the use of vedolizumab in patients with a controlled chronic severe infection or a history of recurring severe infections. Patients should be monitored closely for infections before, during and after treatment. Before starting treatment with vedolizumab, screening for tuberculosis may be considered according to local practice. Some integrin antagonists and some systemic immunosuppressive agents have been associated with progressive multifocal leukoencephalopathy (PML), which is a rare and often fatal opportunistic infection caused by the John Cunningham (JC) virus. By binding to the α4β7 integrin expressed on gut-homing lymphocytes, vedolizumab exerts an immunosuppressive effect specific to the gut. No systemic immunosuppressive effect was noted in healthy subjects. Healthcare professionals should monitor patients on vedolizumab for any new onset or worsening of neurological signs and symptoms, and consider neurological referral if they occur. If PML is suspected, treatment with vedolizumab must be withheld; if confirmed, treatment must be permanently discontinued. Typical signs and symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body, clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. The progression of deficits usually leads to death or severe disability over weeks or months.

Malignancies
The risk of malignancy is increased in patients with ulcerative colitis and Crohn’s disease. Immunomodulatory medicinal products may increase the risk of malignancy.

Prior and concurrent use of biological products
No vedolizumab clinical trial data are available for patients previously treated with natalizumab. No clinical trial data for concomitant use of vedolizumab with biologic immunosuppressants are available. Therefore, the use of vedolizumab in such patients is not recommended.

Vaccinations
Prior to initiating treatment with vedolizumab all patients should be brought up to date with all recommended immunizations. Patients receiving vedolizumab may receive non-live vaccines (e.g., subunit or inactivated vaccines) and may receive live vaccines only if the benefits outweigh the risks.

Adverse reactions include: nasopharyngitis, headache, arthralgia, upper respiratory tract infection, bronchitis, influenza, sinusitis, cough, oropharyngeal pain, nausea, rash, pruritus, back pain, pain in extremities, pyrexia, fatigue, injection site reactions and anaphylaxis.

Injection Site Reactions (subcutaneous vedolizumab)
No clinically relevant differences in the overall safety profile and adverse events were observed in patients who received subcutaneous vedolizumab compared to the safety profile observed in clinical studies with intravenous vedolizumab with the exception of injection site reactions (with subcutaneous administration only). Injection-site reactions were mild or moderate in intensity, and none were reported as serious.

Please consult with your local regulatory agency for approved labeling in your country.

For EU audiences, please see the Summary of Product Characteristics (SmPC) for ENTYVIO®.
For U.S. audiences, please see the full Prescribing Information, including Medication Guide for ENTYVIO® IV.

Takeda in Gastroenterology
We believe that GI (gastrointestinal) and liver diseases are not just life-disrupting conditions, but diseases that can impact a patient’s quality of life.28,29 Beyond a fundamental need for effective treatment options, we understand that improving patients’ lives also depends on their needs being recognized. With nearly 30 years of experience in gastroenterology, Takeda has made significant strides in addressing GI 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 in new areas of unmet need for patients who have celiac disease, eosinophilic esophagitis, alpha-1 antitrypsin-associated liver disease and Crohn’s disease, among others. Together with researchers, patient groups and more, we are working to advance scientific research and clinical medicine in GI.

About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit https://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.

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2 Entyvio EPAR _ 20/02/2019 Entyvio - EMEA/H/C/002782_ European Medicines Agency - Entyvio _ Annex I Summary of product characteristics. Committee For Medicinal Products For Human Use. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/entyvio. Last updated: May 2020. Last accessed: December 2021. 
3 Nishida Y, Hosomi S, Yamagami H, et al. Novel prognostic biomarkers of pouchitis after ileal pouch-anal anastomosis for ulcerative colitis: Neutrophil-to-lymphocyte ratio. PLOS ONE https://doi.org/10.1371/journal.pone.0241322 October 26, 2020. 
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5 Verstockt B, Claeys C, Van Assche G, et al. P624 Vedolizumab can induce clinical remission in patients with chronic antibiotic-refractory pouchitis: A retrospective single-centre experience. J Crohns Colitis. 2018;12(supplement 1):S425. 
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8 Phase 4 Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis (EARNEST). Available at: https://clinicaltrials.gov/ct2/show/NCT02790138. Last updated: 30 June 2021. Last accessed: December 2021. 
9 Travis S, Osterman M, Danese S, Gionchetti P, Lowenberg M, Lindner D, et al. P0448 Efficacy and Safety of Intravenous Vedolizumab for Treatment of Chronic pouchitis: Results of The Phase 4 EARNEST Trial. United European Gastroenterol J. 2021 Oct;9(9_suppl):531. 
10 Hirsch A, Tulchinsky H, Maharshak N. P693 Vedolizumab treatment for pouch inflammation. J Crohns Colitis. 2019;13(supplement 1):S467. 
11 Ribaldone DG, Pellicano R, Saracco GM, et al. Vedolizumab for treatment of chronic refractory pouchitis: a systematic review with pool analysis. Rev Esp Enferm Dig. 2020;112(1):59–63. 
12 Gregory MH, Hicks SB, Hoversten P, et al. Mo1900 - Vedolizumab for the treatment of pouchitis. Gastroenterology. 2018;154(6):S844-S845. 
13 Sandborn WJ, Pardi DS. Clinical management of pouchitis. Gastroenterology. 2004;127(6):1809–14. 
14 Baumgart DC, Carding SR. Inflammatory bowel disease: cause and immunobiology. Lancet. 2007;369:1627-1640. 
15 Baumgart DC, Sandborn WJ. Crohn’s disease. Lancet. 2012;380:1590-1605. 
16 Torres J, Billioud V, Sachar DB, et al. Ulcerative colitis as a progressive disease: the forgotten evidence. Inflamm Bowel Dis. 2012;18:1356-1363. 
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18 Feuerstein JD, Cheifetz AS. Crohn’s disease: Epidemiology, diagnosis and management. Mayo Clin Proc. 2017;92:1088-1103. 
19 Sands BE. From symptom to diagnosis: clinical distinctions among various forms of intestinal inflammation. Gastroenterology. 2004;126:1518-1532. 
20 Henckaerts L, Pierik M, Joossens M, et al. Mutations in pattern recognition receptor genes modulate seroreactivity to microbial antigens in patients with inflammatory bowel disease. Gut. 2007;56:1536-1542. 
21 Kaser A, Zeissig S, Blumberg RS. Genes and environment: How will our concepts on the pathophysiology of IBD develop in the future? Dig Dis. 2010;28:395-405. 
22 Entyvio Prescribing Information. Available at: https://general.takedapharm.com/ENTYVIOPI. Last updated: March 2020. Last accessed: December 2021. 
23 Soler D, Chapman T, Yang LL, et al. The binding specificity and selective antagonism of vedolizumab, an anti-α4β7 integrin therapeutic antibody in development for inflammatory bowel diseases. J Pharmacol Exp Ther. 2009;330:864-875. 
24 Briskin M, Winsor-Hines D, Shyjan A, et al. Human mucosal addressin cell adhesion molecule-1 is preferentially expressed in intestinal tract and associated lymphoid tissue. Am J Pathol. 1997;151:97‑110. 
25 Eksteen B, Liaskou E, Adams DH. Lymphocyte homing and its roles in the pathogenesis of IBD. Inflamm Bowel Dis. 2008;14:1298‑1312. 
26 Wyant T, Fedyk E, Abhyankar B. An overview of the mechanism of action of the monoclonal antibody vedolizumab. J Crohns Colitis. 2016;10:1437-1444. 
27 Takeda data on file (VV-SUP-91507): Vedolizumab Patient Exposure from Marketing Experience. 2021. 
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Copyright 2021 Takeda Pharmaceutical Company Limited. All rights reserved. Takeda and the Takeda Logo are registered trademarks of Takeda Pharmaceutical Company Limited.

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