- Positive opinion paves way for first new treatment option in hidradenitis suppurativa (HS) in nearly a decade
- Committee for Medicinal Products for Human Use (CHMP) opinion based on robust Phase III data showing Cosentyx® (secukinumab) provided rapid symptom relief from as early as Week 4, with response rates continuing to improve up to 1 year1–4
- Safety findings were consistent with the known safety profile of Cosentyx across its five approved indications1
- Regulatory decision from the US Food and Drug Administration (FDA) expected later this year
Basel, April 26, 2023 — Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion and recommended granting a marketing authorization for Cosentyx® (secukinumab) in adults with active moderate to severe hidradenitis suppurativa (HS).
“HS is an under-treated inflammatory skin disease, and I regularly see its devastating impact in my practice. We need more options that can address its multiple signs and symptoms, especially boil-like abscesses, pain and scarring, and bring fast, long-lasting results,” said Professor Christos C. Zouboulis, President of the European Hidradenitis Suppurativa Foundation, Director of the Departments of Dermatology, Venereology, Allergology and Immunology, Staedtisches Klinikum Dessau and Founding Professor of Dermatology and Venereology at the Brandenburg Medical School, Germany. “Today’s news gives me hope that we may soon have a new option to offer our patients in Europe.”
“HS pain can be excruciating at times, limiting my ability to do everyday tasks such as dressing, bathing, walking, exercise, cooking and cleaning. It’s humbling to have to ask others to help tie my shoelaces. Beyond the pain, the drainage, fatigue and other HS symptoms impact my relationships, intimacy, mental health, work and finances. New treatment options are needed to help improve the lives for people with HS,” said Dr. Barry McGrath, PhD, Acting CEO, HS Ireland.
HS affects 1 in 100 people worldwide5, and in Europe, there are around 200,000 people currently living with moderate to severe stages of the condition6. The impact of disease is substantial, even for those on treatment, as there is currently only one approved biologic treatment for HS, and around 50% of patients can lose response7. HS causes boil-like abscesses that can burst and become open wounds that can result in irreversible scarring, often in the most intimate parts of the body5,8. Patients describe their HS-related pain as the most debilitating symptom, which worsens as disease severity increases5,8.
The positive CHMP opinion is based on robust results from two trials in the largest Phase III program in HS, SUNSHINE and SUNRISE9,10. The data showed that treatment response rates in patients randomized to Cosentyx continued to improve beyond the primary endpoint analysis at Week 16 to more than 55% of patients achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 521. Additionally, approximately 50% of patients randomized to Cosentyx had a meaningful reduction in HS-related pain at Week 521. Safety findings were consistent with the known safety profile of Cosentyx in its approved dermatologic and rheumatologic diseases and are further supported by data from 8 years of real-world use1. The full results were recently published in The Lancet1.
“This positive CHMP opinion brings us one step closer to offering the first new HS treatment in nearly a decade,” said Marie-France Tschudin, President of Novartis Innovative Medicines International and Chief Commercial Officer. “If approved, Cosentyx will provide a much-needed alternative to support the underserved community of approximately 200,000 people with moderate to severe HS in Europe, many of whom are living with painful, uncontrolled symptoms.”
The recommendation for Cosentyx in HS will be referred to the European Commission, which is expected to deliver a final decision within 2 months. The Phase III results from SUNSHINE and SUNRISE have also been submitted to the US Food and Drug Administration with a decision expected later this year.
About the SUNSHINE and SUNRISE trials1,9,10
The SUNSHINE (NCT03713619) and SUNRISE (NCT03713632) trials comprise the largest Phase III program in hidradenitis suppurativa (HS), with a combined enrollment of more than 1,000 patients in 40 countries. SUNSHINE and SUNRISE are identical, global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies that evaluated the short- (16 weeks) and long-term (up to 52 weeks) efficacy, safety and tolerability of two dose regimens of Cosentyx in adults with moderate to severe HS. A Hidradenitis Suppurativa Clinical Response (HiSCR), the primary endpoint in the two pivotal trials, is defined as at least a 50% decrease in abscess and inflammatory nodule (AN) count with no increase in the number of abscesses and/or draining tunnels. Results at Week 16 showed that a significantly higher proportion of patients achieved a HiSCR when treated with Cosentyx 300 mg dosed every 2 weeks (after standard weekly loading doses), compared with placebo in both the SUNSHINE and SUNRISE trials (45.0% vs 33.7% [P = .0070] and 42.3% vs 31.2% [P = .0149], respectively). A greater proportion of patients randomized to Cosentyx 300 mg dosed every 4 weeks (after standard weekly loading doses) achieved a HiSCR compared with placebo in both SUNSHINE (41.8% vs 33.7% [P = .0418]) and SUNRISE (46.1% vs 31.2% [P = .0022]) trials; however, this improvement was only statistically significant in SUNRISE. Secondary endpoints included the percentage change from baseline in AN count, proportion of patients experiencing a flare, and proportion of patients with a skin pain numeric rating scale 30 response after 16 weeks of treatment.
An exploratory analysis assessed the long-term effects of Cosentyx for each of the primary and secondary endpoints for up to 52 weeks. HiSCR values observed at Week 16 following either dose regimen of Cosentyx were improved over time to Week 52 (SUNSHINE: SECQ2W [56.4%]; SECQ4W [56.3%]; SUNRISE: SECQ2W [65.0%]; SECQ4W [62.2%]), with rapid improvements seen in patients who switched from placebo at Week 16. The safety profile was consistent with that of Cosentyx in its existing indications.
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) and non-radiographic axial spondyloarthritis (nr-axSpA)11,12. Cosentyx is a proven medicine and 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 long-term safety and efficacy across moderate to severe plaque psoriasis, PsA and AS13–19. These data strengthen the position of Cosentyx as a treatment across AS, nr-axSpA, PsA, moderate to severe plaque psoriasis (adult and pediatric) and two subtypes of juvenile idiopathic arthritis (JIA), enthesitis-related arthritis and juvenile psoriatic arthritis12. More than 1 million patients have been treated with Cosentyx worldwide since its launch in 201520. Cosentyx is approved in more than 100 countries21, most recently gaining approval for JIA in the US and Europe22,23.
About hidradenitis suppurativa (HS)
HS is a painful and recurrent inflammatory skin disease5. It causes boil-like abscesses that can burst, creating open wounds, often in the most intimate parts of the body, resulting in irreversible scarring5,8. It can take 10 years to get a diagnosis, even though HS affects approximately 1 in 100 people globally5,24. There is currently only one approved biologic treatment and around 50% of patients treated can lose response7. In advanced cases, healthcare professionals often consider surgery to remove abscesses, an invasive procedure that frequently results in additional scarring8. HS impacts a patient’s quality of life more than any other skin disease, and people living with HS often experience comorbidities such as obesity, diabetes, arthritis and depression8,25,26.
Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
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References
1. Kimball AB, Jemec GBE, Alavi A, et al. Secukinumab in moderate to severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and 52 results of two identical, double-blind, placebo-controlled, phase 3 randomised trials. Lancet 2023; 401: 747–761.
2. Data on file. NCT03713619 and NCT03713632 (SUNSHINE and SUNRISE): Pooled Data Tables. Novartis Pharmaceuticals Corp; 2022.
3. Data on file. NCT03713619 and NCT03713632 (SUNSHINE and SUNRISE): Summary of Clinical Efficacy. Novartis Pharmaceuticals Corp; 2022.
4. Data on file. NCT03713619 and NCT03713632 (SUNSHINE and SUNRISE): Clinical Study Program post-hoc analysis of skin pain NRS severity. Novartis Pharmaceuticals Corp; 2022.
5. MedLine Plus. Hidradenitis suppurativa [online]. Available at: https://medlineplus.gov/genetics/condition/hidradenitis-suppurativa/ [Last accessed: April 2023].
6. Data on file. Novartis Pharmaceuticals Corp; March 2023.
7. Kimball AB, Okun MM, Williams DA, et al. Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa. N Engl J Med 2016; 375: 422–434.
8. Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev Dis Primers 2020; 6: 18.
9. 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: April 2023].
10. 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: April 2023].
11. Girolomoni G, Mrowietz U, Paul C. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol 2012; 167: 717–724.
12. 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: April 2023].
13. 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: e001005.
14. 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: 1507–1514.
15. 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: 18–25.
16. Data on file. CAIN457F2310 (MEASURE 1 and 2): Pooled Safety Data. Novartis Pharmaceuticals Corp; July 23, 2018.
17. Data on file. CAIN457F2310 and CAIN457F2305 summary of 5-year clinical safety in (ankylosing spondylitis). Novartis Pharmaceuticals Corp; May 2019.
18. Data on file. CAIN457F2312 (FUTURE 2): 5 year-interim report. Novartis Pharmaceuticals Corp; May 2019.
19. 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: 1137–1146.
20. Data on file. COSENTYX Access. Novartis Pharmaceuticals Corp; January 2023.
21. Data on file. COSENTYX Approvals. Novartis Pharmaceuticals Corp; March 2023.
22. Novartis AG. 2021. Novartis Cosentyx® receives FDA approval for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis. [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-fda-approval-treatment-children-and-adolescents-enthesitis-related-arthritis-and-psoriatic-arthritis [Last accessed: April 2023].
23. Novartis AG. 2022. Novartis Cosentyx® (secukinumab) receives positive CHMP opinion for expanded use in childhood arthritic conditions. [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-cosentyx-secukinumab-receives-positive-chmp-opinion-expanded-use-childhood-arthritic-conditions [Last accessed: April 2023].
24. 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: 421–430.
25. Mac Mahon J, Kirthi S, Byrne N, et al. An Update on Health-Related Quality of Life and Patient-Reported Outcomes in Hidradenitis Suppurativa. Patient Relat Outcome Meas 2020; 11: 21–26.
26. Montero-Vílchez T, Sánchez-Díaz M, Martínez-López A, et al. Quality of Life in Patients with Skin Disease and Their Cohabitants. In: Jasneth M, Sage A, Medhane C, Eds. Health-Related Quality of Life. Rijeka: IntechOpen; 2021: Ch. 5.
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