Novartis Cosentyx® (secukinumab) approved by SMC as the first biologic treatment in Scotland for chronic inflammatory skin condition since 2016

• Cosentyx^® (secukinumab) has received positive advice from the Scottish Medicines Consortium for the treatment of active moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults with an inadequate response to conventional systemic HS therapy¹

• HS is a painful, chronic and progressive immunological skin disease with over 50% of people reporting a mental health impact^2,3

• HS affects approximately 2% of the Scottish population⁴

• Secukinumab, an interleukin-17A inhibitor, has a generally well tolerated safety profile, with 8 years of real-world use in over 1 million patients globally^5-7

London, 12 February 2024 — Today, Novartis announced that, following positive advice from the Scottish Medicines Consortium (SMC), Cosentyx^® (secukinumab) is now available in Scotland on the NHS. It is licensed for adults with active moderate to severe hidradenitis suppurativa (HS) (acne inversa) who have responded inadequately to conventional systemic HS therapy¹. The advice applies for use in adult patients with active moderate to severe HS for whom adalimumab is contraindicated or otherwise unsuitable, including those who have failed to respond or have lost response to prior adalimumab treatment.

“We are delighted that the SMC has decided to make secukinumab available to eligible people in Scotland living with HS. Those living with the condition often experience debilitating pain, which can make everyday tasks such as dressing, bathing and sitting at a desk chair really challenging”, said Phil Brady, Chief Operating Officer at the British Skin Foundation. “HS can also have a substantial impact on many other aspects of a person’s life, such as their mental health and relationships. New treatment options are needed to help the HS community find relief from the burden of this disease.”

Secukinumab is the second biologic treatment option to receive positive SMC advice for the treatment of HS, offering a new option to help patients manage their condition⁸. HS is a long-term, painful, chronic and progressive inflammatory skin disease that causes recurring boil-like lumps that can burst into open wounds, leading to irreversible scarring, often in the most intimate parts of the body^2,9. HS affects approximately 2% of the Scottish population, and on average, it takes 10 years for people living with HS to receive a correct diagnosis, resulting in disease progression and significantly impacting their quality of life^3,4,9,10.

“Hidradenitis suppurativa (HS) is an undertreated and debilitating disease. It causes considerable pain, distress and unpleasant symptoms to sufferers. Until now, there has only been one approved treatment for HS (adalimumab), which may not be suitable for everyone”, said Dr Fiona Craig, Consultant Dermatologist, Scotland. “The approval of secukinumab for HS by the SMC is a positive step for sufferers of this condition in Scotland and provides physicians in Scotland with a second treatment option that has been shown to reduce disease activity and improve the quality of life for patients with HS.” 

The approval by the SMC is based on robust results from two trials in the largest Phase III programme in HS to date, SUNSHINE and SUNRISE^11-13. The data showed that treatment response rates in patients randomised to secukinumab continued to improve beyond the primary endpoint analysis at Week 16, with more than 55% of patients achieving a Hidradenitis Suppurativa Clinical Response at Week 52^11-13. Additionally, approximately 50% of patients randomised to secukinumab had a reduction in HS-related pain at Week 52^11-13. Safety findings were consistent with the generally well tolerated safety profile of secukinumab in its approved dermatological and rheumatological licensed indications, further supported by data from 8 years of real-world use^5,13. The full results were recently published in The Lancet¹³.

“Knowing how HS has a profound impact on people’s personal relationships and quality of life, together with the actors in the healthcare system, we refuse to accept ‘good enough’ and we challenge the idea that people with inflammatory diseases must settle for a life of limitations”, said Marie-Andrée Gamache, Country President and Managing Director, Novartis UK and Ireland. “Today’s SMC decision is a result of this commitment, reimagining healthcare for people living with HS. To date secukinumab has been used to treat over 1 million patients worldwide across all indications and could now provide another treatment option to eligible people living with HS in Scotland.”

About Cosentyx^® (secukinumab)
Cosentyx is the first and only fully human biologic that directly inhibits interleukin-17A, an important cytokine involved in the inflammation of psoriatic arthritis (PsA), moderate to severe plaque psoriasis, ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA) and hidradenitis suppurativa (HS)^6,14,15. Cosentyx is a medicine that has been studied clinically for more than 14 years. The medicine is backed by robust evidence, including 5 years of clinical data in adults supporting its long-term safety profile and efficacy across moderate to severe plaque psoriasis, PsA and AS^14,16-21.These data strengthen the position of Cosentyx as a treatment option across moderate to severe AS, nr-axSpA, PsA, HS, moderate to severe plaque psoriasis (adult and paediatric) and two subtypes of juvenile idiopathic arthritis; enthesitis-related arthritis and juvenile psoriatic arthritis⁶. More than 1 million patients have been treated with Cosentyx worldwide across indications since its launch in 2015^5-7. Cosentyx is approved in more than 100 countries, most recently gaining approval for HS in Europe^22,23. We are continuing to explore the potential of Cosentyx in other indications in areas of high unmet need.

About Novartis

Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease.

In the UK, we champion health and lives through pioneering NHS partnerships, innovative collaborations and a clear focus on the greatest healthcare challenges we all face. We are where science meets hope.

To reimagine medicine with us, visit our website at https://www.novartis.com/uk-en/ and connect on LinkedIn, Facebook, X/Twitter and Instagram.

References

1. SMC Medicines advice. Secukinumab (Cosentyx). Treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS therapy. Available at: https://www.scottishmedicines.org.uk/medicines-advice/secukinumab-cosentyx-full-smc2592/ [Last accessed: February 2024].
2. MedLine Plus. Hidradenitis suppurativa [online]. Available at: https://medlineplus.gov/genetics/condition/hidradenitis-suppurativa/ [Last accessed: February 2024].
3. OHE. The Burden of Hidradenitis Suppurativa on Patients, the NHS and Society [online]. Available at: https://www.ohe.org/publications/burden-hidradenitis-suppurativa-recommendations [Last accessed: February 2024].
4. The Scottish Parliament. PE01682: Access to specialist support for hidradenitis suppurativa sufferers in Scotland. Available at: https://archive2021.parliament.scot/gettinginvolved/petitions/PE01600-PE01699/PE01682_BackgroundInfo.aspx [Last accessed: February 2024].
5. Data on file. COSENTYX Access. Novartis Pharmaceuticals Corp; November 2022.
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7. Novartis Europharm Limited. Cosentyx® (secukinumab): Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/cosentyx-epar-product-information_en.pdf [Last accessed February 2024].
8. Scottish Medicines Consortium. Adalimumab (Humira®) is accepted for use within NHS Scotland. Available at: https://www.scottishmedicines.org.uk/media/1191/adalimumab__humira__final_april_2016_for_website.pdf [Last accessed: February 2024].
9. Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev Dis Primers.2020;6(1):18.
10. Kokolakis G, Wolk K, Schneider-Burrus S, et al. Delayed Diagnosis of Hidradenitis Suppurativa and Its Effect on Patients and Healthcare System. Dermatology 2020;236(5):421-430.
11. ClinicalTrials.gov. Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS) (SUNRISE). NCT03713632. Available at: https://clinicaltrials.gov/ct2/show/NCT03713632. [Last accessed: February 2024].
12. ClinicalTrials.gov. This is a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS). (SUNSHINE). NCT03713619. Available at: https://clinicaltrials.gov/ct2/show/NCT03713619. [Last accessed: February 2024].
13. Kimball AB, Jemec GBE, Alavi A, et al. Secukinumab in moderate-to-severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and week 52 results of two identical, multicentre, randomised, placebo-controlled, double-blind phase 3 trials. Lancet 2023;401(10378):747-761.
14. Mease PJ, Kavanaugh A, Reimold A, et al. Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Psoriatic Arthritis: Final 5-year Results from the Phase 3 FUTURE 1 Study. ACR Open Rheumatol 2020; 2(1): 18-25.
15. Girolomoni G, Mrowietz U, Paul C. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol 2012; 167(4): 717-724.
16. McInnes IB, Mease PJ, Kirkham B, et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2015; 386(9999): 1137-1146.
17. Baraliakos X, Braun J, Deodhar A, et al. Long-term efficacy and safety of secukinumab 150 mg in ankylosing spondylitis: 5-year results from the phase III MEASURE 1 extension study. RMD Open 2019; 5(2): e001005.
18. Bissonnette R, Luger T, Thaçi D, et al. Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol 2018; 32(9): 1507-1514.
19. Data on file. CAIN457F2310 (MEASURE 1 and 2): Pooled Safety Data. Novartis Pharmaceuticals Corp; July 23, 2018.
20. Data on file. CAIN457F2310 and CAIN457F2305 summary of 5-year clinical safety in (ankylosing spondylitis). Novartis Pharmaceuticals Corp; May 2019.
21. Data on file. CAIN457F2312 (FUTURE 2): 5 year-interim report. Novartis Pharmaceuticals Corp; May 2019.
22. Novartis AG. 2023. Novartis receives European approval for Cosentyx® as first and only IL-17A inhibitor for hidradenitis suppurativa. [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-receives-european-approval-cosentyx-first-and-only-il-17a-inhibitor-hidradenitis-suppurativa [Last accessed: February 2024].
23. Gottlieb AB, Deodhar A, McInnes IB, et al. Long-term Safety of Secukinumab Over Five Years in Patients with Moderate-to-severe Plaque Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Update on Integrated Pooled Clinical Trial and Post-marketing Surveillance Data. Acta Derm Venereol 2022; 102:adv00698.