- Approval is based on the two largest Phase III trials
conducted in HS – SUNSHINE and SUNRISE – demonstrating the safety
and efficacy of Cosentyx® in HS1
- HS is a chronic, immunological, inflammatory skin condition
estimated to affect 1 in 100 people worldwide causing painful,
boil-like lumps that can lead to open wounds and irreversible
scarring2,3,4
- The new treatment for HS reinforces Novartis' commitment to
delivering new, innovative therapies that improve health outcomes
for patients in Canada
MONTRÉAL, May 22, 2024
/CNW/ - Novartis Pharmaceuticals Canada Inc. (Novartis) is
pleased to announce that Health Canada has granted
Cosentyx® (secukinumab) with a Notice of Compliance
(NOC) for the treatment of adult patients with moderate to severe
hidradenitis suppurativa (HS) (acne inversa) who have
responded inadequately to conventional systemic hidradenitis
suppurativa therapy – representing a safe and efficacious new
treatment option for Canadians living with the
condition.1
While the exact cause and prevalence of HS is
unknown,2 it is estimated to affect 1-4 per cent of the
Canadian population4 which equates to between 300,000
and 1 million people.5 HS is considered a chronic and
progressive disease, meaning it can worsen over time and have a
significant impact on a patient's everyday life.4
"People living with HS often suffer physically and mentally from
the effects of the condition," said Latoya
Palmer, Founder of Hidradenitis and Me Support Group.
"Ensuring there are a wide range of treatment options is vital for
each individual to find the right path for them."
The safety and efficacy of Cosentyx® was assessed in
the two largest Phase III trials ever conducted in HS – SUNSHINE
(M2301) and SUNRISE (M2302). The global,
multicentre, randomized, double-blind, placebo-controlled
clinical trials studied 1,084 adult patients with moderate to
severe HS.1
"Patients who have been diagnosed with advanced HS often have
limited treatment options available to them," said Dr. Susan Poelman, Dermatologist and President of
the HS Foundation in Canada. "The
approval of a new treatment option for HS is a welcome new addition
for people living with the condition and will bring hope to
patients that have achieved suboptimal control with current
available therapies."
In addition to HS, Cosentyx® has been previously
approved for use in Canada for a
variety of conditions including plaque psoriasis, psoriatic
arthritis, axial spondyloarthritis and juvenile idiopathic
arthritis.1 Given its well-known and proven safety
profile, Cosentyx® will provide physicians and their
patients with more treatment options to decide on the most
appropriate course of action to treat their HS.
"This approval will offer a new treatment option for patients
currently living with HS," added Dr. Mark
Kirchhof, Division Head of Dermatology in the Faculty of
Medicine at the University of Ottawa
and The Ottawa Hospital. "Cosentyx® will provide
dermatologists with a familiar treatment for this complex
condition."
"More than 1 million patients have been treated with
Cosentyx® worldwide since its launch in 2015, and we are
proud that is now available in Canada as a much-needed treatment to those
suffering with HS," said Mark
Vineis, Country President Novartis Pharmaceuticals Canada
Inc. "This approval is another example of Novartis' commitment to
bringing innovative medicines to improve patient outcomes in
Canada."
About Novartis
Novartis is a focused 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. Our medicines reach more than 250 million people
worldwide. Reimagine medicine with us: Visit us at
https://www.novartis.com and connect with us on LinkedIn,
Facebook, X/Twitter and Instagram.
In Canada, Novartis
Pharmaceuticals Canada Inc. employs approximately 600 people to
serve the evolving needs of patients and the healthcare system, and
invests over $30 million in R&D
yearly in the country. For more information visit
www.novartis.ca.
About the SUNSHINE and SUNRISE
trials6,7,8
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
evaluated the short- (16 weeks) and long-term (up to 52 weeks)
efficacy, safety and tolerability of two dose regimens of
Cosentyx® (secukinumab) in adults with moderate to
severe HS.
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).9,10 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
AS.11,12,13,14,15,16,17 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
arthritis.9 More than 1 million patients have been
treated with Cosentyx® worldwide since its launch in
2015.
Media Contact
Karla Fuentes Arellano
Communications & Engagement Lead
E-mail: camlph.communications@novartis.com
M +1 514 633 7873
426329E
References
____________________________________
|
1
Cosentyx® Product
Monograph. May 21, 2024.
|
2
NHS. Hidradenitis Suppurativa (HS). Accessed on March 2, 2024.
Available at:
https://www.nhs.uk/conditions/hidradenitis-suppurativa/.
|
3
American Academy of Dermatology. Hidradenitis Suppurativa:
Overview. Accessed on March 2, 2024. Available at:
https://www.aad.org/public/diseases/a-z/hidradenitis-suppurativa-overview#:~:text=Hidradenitis%20suppurativa%20(HS)%20is%20a,and%20treatment%20of%20this%20condition.
|
4 HS
Heros. What is HS? Accessed on March 2, 2024. Available at:
https://hsheroes.ca/what-is-hs/.
|
5
Canadian Dermatology Association. Hidradenitis Suppurativa.
Accessed on March 2, 2024. Available at:
https://dermatology.ca/public-patients/skin/hidradenitis-suppurativa/#:~:text=Fifty%20to%20300%20million%20people,people%20in%20Canada%20
|
have%20HS.&text=Hidradenitis%20suppurativa%20(HS)%20is%20a%20chronic%2C%20painful%20skin%20condition,hair%20follicles%20in%20the%20skin.
|
6
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.
Accessed on March 2, 2024. Available at:
https://doi.org/10.1016/S0140-6736(23)00022-3.
|
7
ClinicalTrials.gov. Study of Efficacy and Safety of Two Secukinumab
Dose Regimens in Subjects With Moderate to Severe Hidradenitis
Suppurativa (HS) (SUNRISE). NCT03713632. Accessed on March 2, 2024.
Available at: https://clinicaltrials.gov/ct2/show/NCT03713632.
|
8
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. Accessed on
March 2, 2024. Available at:
https://clinicaltrials.gov/ct2/show/NCT03713619.
|
9
Novartis Europharm Limited. Cosentyx® (secukinumab): Summary of Product
Characteristics. Accessed on March 2, 2024. Available at:
https://www.ema.europa.eu/en/documents/product-information/cosentyx-epar-product-information_en.pdf.
|
10
Girolomoni G, Mrowietz U and Paul C. Psoriasis: rationale for
targeting interleukin-17. Br J Dermatol 2012; 167: 717-724.
Accessed on March 2, 2024. Available at:
https://pubmed.ncbi.nlm.nih.gov/22716185/.
|
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 (FUTURE 2): 5 year-interim report.
Novartis Pharmaceuticals Corp; May 2019.
|
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: 1137-1146.
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SOURCE Novartis Pharmaceuticals Canada Inc.