31.10.2023 21:50:49
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Press Release: FDA approves Novartis Cosentyx(R) -2-
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References
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Pharmaceuticals Corp; October 2023.
2. 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; published online Feb 3. Available at:
https://doi.org/10.1016/S0140-6736(23)00022-3 [Last accessed: February
2023].
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https://medlineplus.gov/genetics/condition/hidradenitis-suppurativa/
https://medlineplus.gov/genetics/condition/hidradenitis-suppurativa/
[Last accessed: March 2022].
4. Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev
Dis Primers 2020;6:18. doi: 10.1038/s41572-020-0149-1
5. 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.
6. 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.
7. Martora F, Megna M, Battista T, et al. Adalimumab, Ustekinumab, and
Secukinumab in the Management of Hidradenitis Suppurativa: A Review of
the Real-Life Experience. Clin Cosmet Investig Dermatol. 2023;16:135-148.
Published 2023 Jan 19. doi:10.2147/CCID.S391356 4.
8. Kimball AB, Jemec GBE, Alavi A, et al. Efficacy and Safety of Secukinumab
in Patients with Moderate to Severe Hidradenitis Suppurativa from the
Phase 3 SUNSHINE and SUNRISE Trials. Poster presented at American Academy
of Dermatology (AAD) 2023 Annual Meeting; March 17-21, 2023, New Orleans,
LA.
9. Girolomoni G, Mrowietz U and Paul C. Psoriasis: rationale for targeting
interleukin-17. Br J Dermatol. 2012;167:717-24.
10. McGonagle DG, McInnes IB, Kirkham BW, et al. The role of IL-17A in axial
spondyloarthritis and psoriatic arthritis: recent advances and
controversies. Annals Rheum Dis. 2019;78:1167-1178.
11. 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.
12. 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.
13. 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.
14. Data on file. CAIN457F2310 (MEASURE 1 and 2): Pooled Safety Data.
Novartis Pharmaceuticals Corp; July 23, 2018.
15. Data on file. CAIN457F2310 and CAIN457F2305 summary of 5-year clinical
safety in (ankylosing spondylitis). Novartis Pharmaceuticals Corp; May
2019.
16. Data on file. CAIN457F2312 Data Analysis Report. Novartis Pharmaceuticals
Corp; November 2008.
17. 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;386:1137-46.
18. Data on file. COSENTYX Access. Novartis Pharmaceuticals Corp; January
2023.
19. Novartis AG. 2021. Novartis Cosentyx(R) 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-receiv
es-fda-approval-treatment-children-and-adolescents-enthesitis-related-art
hritis-and-psoriatic-arthritis [Last accessed: February 2023].
20. Novartis Europharm Limited. Cosentyx(R) (secukinumab): Summary of Product
Characteristics. Available
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par-product-information_en.pdf [Last accessed: July 2023].
# # #
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(END) Dow Jones Newswires
October 31, 2023 16:50 ET (20:50 GMT)
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