NICE recommends Revestive® ▼ (teduglutide) for the treatment of adults and children living with Short Bowel Syndrome (SBS)

• Takeda UK Ltd. is pleased to announce that NICE has recommended the use of Revestive^® ▼ (teduglutide) once daily subcutaneous injection as an option for people living with Short Bowel Syndrome (SBS) aged 1 year and above, within their final appraisal document (FAD) published today.^[i], [ii]
• This positive recommendation from NICE means that eligible individuals in England and Wales may now benefit from a treatment that has the potential to reduce their reliance on parenteral nutrition (intravenous nutrients and/or fluids).^[iii],[iv]
• SBS has the potential to be a life limiting condition, associated with reduced quality of life for people living with SBS and their families. ^[v],[vi] 

LONDON, June 1, 2022 /PRNewswire/ -- Takeda UK Ltd. today announced that the National Institute for Health and Care Excellence (NICE), the health technology appraisal body in England and Wales, has published its Final Appraisal Document (FAD) recommending Revestive^® ▼   (teduglutide) once daily subcutaneous injection as an option for people living with Short Bowel Syndrome (SBS) aged 1 year and above.^[ii] Individuals should be stable following a period of intestinal adaptation after surgery.^[vii] 

SBS is a rare, serious and disabling gastrointestinal condition,^[viii],[v] that results from the loss of some or all of the small intestine ^[ix] due to congenital abnormalities, disease or trauma.^[x] As a result of this, people living with SBS lose the ability to absorb enough nutrients and liquid through a normal diet and need to receive life-sustaining nutrition intravenously, known as parenteral nutrition (PN) or parenteral support (PS) – a complex, sophisticated treatment that involves intravenous delivery of nutrition and fluids through a catheter averaging 10-14 hours overnight for 2–7 nights a week.^{[xi], [xii]}

Carolyn Wheatley, Chair of UK patient organisation PINNT (support and advocacy for people on home artificial nutrition) and Mary Foss, Chair of Short Bowel Survivor & Friends, UK charity for parents, families, and carers of children with SBS, issued a joint statement following today's announcement:

"Parenteral nutrition (PN) is associated with significant continuous burden, with little or no respite due to patients needing to be attached to a sophisticated feeding pump for the duration of their time receiving the intravenous nutrition, multiple if not every night a week. It affects normality of all aspects of life, including work, education, intimacy and mental well-being. Whilst PN is part of standard treatment, it is a complex and demanding regimen that provides life-saving nutrition and hydration but does not provide a cure for the underlying condition. Many individuals living with SBS, child or adult, manage a variety of symptoms such as pain, discomfort and sleep deprivation which affects the individual and their family's ability to function normally. A therapeutic option that reduces reliance on PN and offers those living with SBS potential freedom and hope of an improved quality of life is most welcomed by patients and their carers."

The effects of SBS and its treatment with PN can significantly impair quality of life and may be associated with rare, but potentially life-threatening complications such as risk of infection ^[xiii]  thrombosis ^[xiv] and liver disease.^[xv] Reducing the quality-of-life burden of PN and minimising associated complications are key treatment goals for both adults and children.^[xiii]

Leading Consultants Dr Simon Gabe, Gastroenterologist and Chair of the Lennard Jones Intestinal Rehabilitation Unit, UK, and Dr Susan Hill, Paediatric Gastroenterologist at Great Ormond Street Hospital for Children NHS Foundation Trust, London said, "Parenteral nutrition places a huge burden on patients and families, with the patient attached to an infusion pump for 12 hours or more each night. Teduglutide is the first disease modifying treatment available for short bowel syndrome associated with intestinal failure and has the potential to get patients off intravenous nutrition support or decrease the amount they require. Furthermore, when a patient weans off parenteral nutrition and has their central venous catheter removed, they are no longer at risk of life-threatening complications. Teduglutide definitely has a valuable place in the SBS treatment algorithm."

Key evidence behind the NICE recommendation for Revestive was data from the Study of Teduglutide Effectiveness in Parenteral Nutrition-Dependent Short Bowel Syndrome Subjects (STEPS) and STEPS-2 trials.^[xiv],[xvi]

Commenting on the recommendation, Peter Wheatley Price, Market Access Director, Takeda UK & Ireland, said, "We are so grateful for this recommendation and what it means for patients, having worked tirelessly to ensure all people in England and Wales living with SBS have access to this new treatment option which has the potential to transform lives. Up until now the only available treatment for SBS-IF has been to support keeping patients alive rather than to significantly improve intestinal function and quality of life."

This FAD is now subject to a 15 working day appeal period by consultees for the appraisal. Subject to any appeal by consultees, the FAD may be used as the basis of NICE's guidance on the use of Revestive in the National Health Service (NHS).^[i]

Please refer to teduglutide UK Summary of Product Characteristics (SmPC) for more information. https://www.medicines.org.uk/emc/medicine/29315#gref 

Notes to Editors

About Revestive (teduglutide)

Revestive contains the active substance teduglutide, a glucagon-like peptide-2 (GLP-2) analogue.^[ii] In Europe, it is indicated for the treatment of patients aged one year and above with Short Bowel Syndrome (SBS).^[ii],[vii] Patients should be stable following a period of intestinal adaptation after surgery.[ii]^,[vii]  Revestive received Market Authorisation in Europe in 2012 for the treatment of adult patients with SBS, who should be stable following a period of intestinal adaptation after surgery. The European Commission extended the licence for treatment of SBS patients aged one year and above in June 2016.^[xvii]  Revestive was granted approval by the Scottish Medicines Consortium (SMC) for use in Scotland in 2018 for paediatric patients ^[xviii] and in 2020 for adult patients. ^[xix]

About Takeda Pharmaceutical Company

Takeda Pharmaceutical Company Limited is headquartered in Japan and is a global, values-based, R&D-driven biopharmaceutical leader committed to translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Gastroenterology (GI), Neuroscience and Rare Diseases. 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 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.

Additional information about Takeda UK Ltd. is available through its corporate website, www.takeda.com/en-gb.

References

[i] NICE. Final appraisal document: Teduglutide for treating short bowel syndrome (2022). Available at: https://www.nice.org.uk/guidance/gid-ta10842/documents/final-appraisal-determination-document. Accessed June 2022.

[ii] Electronic medicines compendium. Revestive 5 mg powder and solvent for solution for injection (2022). Available at: https://www.medicines.org.uk/emc/medicine/29315#gref. Accessed May 2022.

[iii] Kocoshis S.A., et al. Safety and Efficacy of Teduglutide in Pediatric Patients with Intestinal Failure due to Short Bowel Syndrome: A 24-Week, Phase III Study (2020). Available at: https://pubmed.ncbi.nlm.nih.gov/31495952/. Accessed May 2022.

[iv] Jeppesen P.B., et al. Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure (2012). Available at: https://pubmed.ncbi.nlm.nih.gov/22982184/. Accessed May 2022.

[v] Kelly DG., Tappenden KA., Winkler MF. Short bowel syndrome: highlights of patient management, quality of life, and survival (2014). Available at: https://pubmed.ncbi.nlm.nih.gov/24247092/. Accessed May 2022. 

[vi] Sowerbutts, A., et al. Short bowel syndrome and the impact on patients and their families: a qualitative study (2020). Available at: https://onlinelibrary.wiley.com/doi/full/10.1111/jhn.12803. Accessed May 2022.

[vii] European Medicines Association. Revestive, teduglutide, product information (2022). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002345/WC500132926.pdf. Accessed May 2022.

[viii] European Commission. Regulation (EU) No 536/2014 of the European Parliament and Of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (2014). Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32014R0536. Accessed May 2022.

[ix] Sulkowski JP., Minneci PC. Management of short bowel syndrome (2014). Available at: https://pubmed.ncbi.nlm.nih.gov/24341969/. Accessed May 2022.

[x] Pironi L, et al. ESPEN endorsed recommendations. Definition and classification of intestinal failure in adults (2015). Available at: https://pubmed.ncbi.nlm.nih.gov/25311444/. Accessed May 2022.

[xi] NICE. Teduglutide for treating short bowel Syndrome (2022). Available at: https://www.nice.org.uk/guidance/gid-ta10842/documents/committee-papers. Accessed May 2022.

[xii] Dreesen M., et al. Epidemiology of catheter-related infections in adult patients receiving home parenteral nutrition: a systematic review (2013). Available at: https://pubmed.ncbi.nlm.nih.gov/22959630/. Accessed May 2022.

[xiii] Spencer AU., et al. Pediatric short bowel syndrome: Redefining predictors of success (2005). Available at: https://pubmed.ncbi.nlm.nih.gov/16135926/. Accessed May 2022.

[xiv] Jeppesen PB. Teduglutide, a novel glucagon-like peptide 2 analog, in the treatment of patients with short bowel syndrome (2012). Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3342570/. Accessed May 2022.

[xv] Cavicchi M., et al. Prevalence of Liver Disease and Contributing Factors in Patients Receiving Home Parenteral Nutrition for Permanent Intestinal Failure (2000). Available at: https://pubmed.ncbi.nlm.nih.gov/10744588/. Accessed May 2022.  

[xvi] Schwartz LK., et al. Long-term teduglutide for the treatment of patients with intestinal failure associated with short bowel syndrome (2016). Available at: https://pubmed.ncbi.nlm.nih.gov/26844839/. Accessed May 2022.

[xvii] PR Newswire. Shire Receives Extension of Market Authorization in Europe for REVESTIVE (Teduglutide) for the Treatment of Paediatric Patients with Short Bowel Syndrome (2016). Available at: https://www.prnewswire.com/news-releases/shire-receives-extension-of-market-authorization-in-europe-for-revestive-teduglutide-for-the-treatment-of-paediatric-patients-with-short-bowel-syndrome-sbs-585798821.html. Accessed May 2022.

[xviii] Scottish Medicines Consortium. Advice for teduglutide: paediatric patients (1139/16) (2018). Available at: https://www.scottishmedicines.org.uk/medicines-advice/teduglutide-revestive-fullsubmission-113916/. Accessed May 2022.

[xix] Scottish Medicines Consortium. Advice for teduglutide: patients aged 1 year and above (SMC2225) (2020). Available at: https://www.scottishmedicines.org.uk/medicines-advice/teduglutide-revestive-resub-smc2225/. Accessed May 2022.

Logo - https://mma.prnewswire.com/media/1830807/Takeda_Logo.jpg