Enthesitis-Related Arthritis

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 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 . 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. 426329E References SOURCE Novartis Pharmaceuticals Canada Inc.

Pictured: Novartis logo on building in California/iStock, JHVEPhoto The FDA on Tuesday expanded the label of Novartis’ IL-17A inhibitor Cosentyx (secukinumab) to cover moderate to severe hidradenitis suppurativa in adults, a painful long-term skin condition. Cosentyx is the first and only FDA-approved fully human biologic that directly targets IL-17A cytokine and is the first new biologic treatment option for hidradenitis suppurativa (HS) in almost a decade, according to Novartis’ announcement. With Tuesday’s approval, Cosentyx will now come into competition with AbbVie’s blockbuster antibody Humira (adalimumab), which became the U.S.’s first FDA-approved HS therapy in September 2015. Unlike Cosentyx, Humira targets TNF-alpha, another molecule involved in the pro-inflammatory cascade. This mechanism of action has also won Humira other indications, including rheumatoid arthritis, Crohn’s disease and plaque psoriasis. Cosentyx, a human IgG1 monoclonal antibody, targets IL-17A to block its interaction with the counterpart receptor, thereby suppressing the pro-inflammatory signaling cascade. It was first approved in 2015 and is also indicated for the treatment of plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, enthesitis-related arthritis and non-radiographic axial spondyloarthritis. “HS is one of the most devastating and exhausting skin diseases,” Donna Atherton, founder and chief mission officer at the International Association of Hidradenitis Suppurativa Network, said in a statement. The condition is chronic and systemic and is characterized by boil-like lumps that typically burst into open wounds, which often result in irreversible scarring. HS flare-ups can cause debilitating pain that disrupts work and social participation, as well as pose a heavy emotional and mental toll on patients. Central to the disease’s pathology is the IL-17 pathway, which is dysregulated and overactivated in HS and gives rise to its inflammation-driven symptoms. “The approval of a new treatment option brings fresh hope to me and the HS community that we may find relief from the burden of the disease,” Atherton said. The FDA based its approval on data from the SUNSHINE and SUNRISE studies, the largest Phase III program in HS to date, according to Novartis’ news release. Together, these studies showed that Cosentyx-treated patients achieved significantly higher rates of clinical response compared to placebo. The IL-17A inhibitor demonstrated efficacy as early as week 2, progressively improved through week 16 and persisted until week 52. SUNRISE and SUNSHINE also found a safety pro Cosentyx that was consistent with what had been established in prior studies. Also eyeing a portion of the HS market is UCB, which is advancing the dual IL-17A and IL-17F inhibitor bimekizumab. In March 2023, the company reported clinically meaningful, deep and persistent treatment response in the Phase III BE HEARD I and BE HEARD II studies. At the time, UCB was gearing up for global regulatory submissions for bimekizumab in this indication starting in the third quarter of 2023. Bimekizumab won the FDA’s approval in October 2023 for plaque psoriasis, for which it is sold under the brand name Bimzelx. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Pictured: Novartis’ logo outside its building in S JHVEPhoto/Getty Images The Swiss pharma has set up its challenge to AbbVie’s blockbuster immunosuppressive drug Humira with a label expansion for Cosentyx in hidradenitis suppurativa, a painful long-term skin condition. Pictured: Novartis logo on building in California/iStock, JHVEPhoto The FDA on Tuesday expanded the label of Novartis ’ IL-17A inhibitor Cosentyx (secukinumab) to cover moderate to severe hidradenitis suppurativa in adults, a painful long-term skin condition. Cosentyx is the first and only FDA-approved fully human biologic that directly targets IL-17A cytokine and is the first new biologic treatment option for hidradenitis suppurativa (HS) in almost a decade, according to Novartis’ announcement. With Tuesday’s approval, Cosentyx will now come into competition with AbbVie’s blockbuster antibody Humira (adalimumab), which became the U.S.’s first FDA-approved HS therapy in September 2015. Unlike Cosentyx, Humira targets TNF-alpha, another molecule involved in the pro-inflammatory cascade. This mechanism of action has also won Humira other indications , including rheumatoid arthritis, Crohn’s disease and plaque psoriasis. Cosentyx , a human IgG1 monoclonal antibody, targets IL-17A to block its interaction with the counterpart receptor, thereby suppressing the pro-inflammatory signaling cascade. It was first approved in 2015 and is also indicated for the treatment of plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, enthesitis-related arthritis and non-radiographic axial spondyloarthritis. “HS is one of the most devastating and exhausting skin diseases,” Donna Atherton, founder and chief mission officer at the International Association of Hidradenitis Suppurativa Network, said in a statement. The condition is chronic and systemic and is characterized by boil-like lumps that typically burst into open wounds, which often result in irreversible scarring. HS flare-ups can cause debilitating pain that disrupts work and social participation, as well as pose a heavy emotional and mental toll on patients. Central to the disease’s pathology is the IL-17 pathway , which is dysregulated and overactivated in HS and gives rise to its inflammation-driven symptoms. “The approval of a new treatment option brings fresh hope to me and the HS community that we may find relief from the burden of the disease,” Atherton said. The FDA based its approval on data from the SUNSHINE and SUNRISE studies, the largest Phase III program in HS to date, according to Novartis’ news release. Together, these studies showed that Cosentyx-treated patients achieved significantly higher rates of clinical response compared to placebo. The IL-17A inhibitor demonstrated efficacy as early as week 2, progressively improved through week 16 and persisted until week 52. SUNRISE and SUNSHINE also found a safety pro Cosentyx that was consistent with what had been established in prior studies. Also eyeing a portion of the HS market is UCB, which is advancing the dual IL-17A and IL-17F inhibitor bimekizumab. In March 2023, the company reported clinically meaningful, deep and persistent treatment response in the Phase III BE HEARD I and BE HEARD II studies. At the time, UCB was gearing up for global regulatory submissions for bimekizumab in this indication starting in the third quarter of 2023. Bimekizumab won the FDA’s approval in October 2023 for plaque psoriasis, for which it is sold under the brand name Bimzelx. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com .