Novartis Cosentyx® receives FDA approval for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis

• New approvals are based on JUNIPERA trial data showing Cosentyx® (secukinumab) demonstrated reduced flare risk versus placebo and improvement in disease activity observed over two years across both enthesitis-related arthritis (ERA) and psoriatic arthritis (PsA) in pediatric patients(1)
• Safety in these pediatric populations was consistent with the known safety profile of Cosentyx(2)
• Cosentyx is the only biologic treatment approved for children and adolescents for both ERA (4 years of age and older) and PsA (2 years of age and older) in the US

EAST HANOVER, N.J., Dec. 22, 2021 -- Novartis, a leader in rheumatology and immuno-dermatology, today announced the US Food and Drug Administration (FDA) has approved Cosentyx^® (secukinumab) for the treatment of active enthesitis-related arthritis (ERA) in patients four years and older, and active psoriatic arthritis (PsA) in patients two years and older¹. Cosentyx is now the first biologic indicated for ERA and the only biologic treatment approved for both ERA and PsA in pediatric patients in the US. These are the second and third approvals for Cosentyx in a pediatric population in the US, and Cosentyx now has a total of five indications across rheumatology and dermatology¹.

"Prior research suggests that despite receiving treatment, some children and adolescents with PsA or ERA can continue to experience symptoms," said Hermine Brunner, MD, Cincinnati Children's Hospital. "The findings from the Phase III JUNIPERA trial show that pediatric patients treated with secukinumab demonstrated marked responses throughout the treatment period. This approval is positive news for some patients who continue to struggle with painful symptoms like inflammation of the joints and swollen fingers and toes."

ERA and juvenile PsA (JPsA), subtypes of juvenile idiopathic arthritis (JIA), are autoimmune diseases^3,4,5. ERA is characterized by joint swelling and pain where tendons and ligaments attach to bone and may present with low back pain or tenderness at the palpation of the hips⁶. JPsA is characterized by joint swelling and skin psoriasis and may present with nail changes, inflammation of fingers and/or toes, or psoriatic skin changes in a first-degree relative⁶. If left untreated, they can lead to high levels of pain and disability^3,4,5.

"The FDA approvals for JPsA and ERA follow the approval of Cosentyx as a first-line systemic treatment for pediatric psoriasis earlier this year, and further reinforce the commitment of Novartis to the pediatric community," said Victor Bulto, Head, US Pharmaceuticals, Novartis Pharmaceuticals Corporation. "Cosentyx is a proven medicine with a history of efficacy and safety across several systemic inflammatory conditions, with more than 500,000 patients treated worldwide since launch."

The approved pediatric dosing for Cosentyx in children and adolescents is 75 mg (body weight: 15 kg to less than 50 kg) or 150 mg (50 kg or more). It is administered as a subcutaneous injection by a pre-filled syringe or Sensoready^® pen every four weeks after initial loading doses¹. With appropriate guidance/instruction from a healthcare professional, Cosentyx can be administered by an adult caregiver outside of a healthcare provider's office via a single-dose prefilled syringe or Sensoready^® pen.

The approval is based on data from the Phase III JUNIPERA study, a two-year, three-part, double-blind, placebo-controlled, randomized-withdrawal trial that enrolled 86 children and adolescents aged 2 to 17 years with a confirmed diagnosis of ERA or JPsA according to a modified International League of Associations for Rheumatology classification criteria⁷. The primary endpoint of the study was time to flare in the treatment period 2 (Week 12 to Week 104)⁷. In children and adolescents ages 2 to 17 years old, the study demonstrated that patients with active JPsA (n = 34; mean age: 12.2) treated with Cosentyx had a significantly longer time to flare, showing a 85% reduction in the risk of flare (P<0.001) versus placebo^1,8. The study also demonstrated that patients with active ERA (n = 52; mean age: 13.7) treated with Cosentyx had a longer time to flare, showing a 53% reduction in the risk of flare versus placebo^1,8. Safety in this pediatric population was consistent with the known safety profile of Cosentyx for the treatment of plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis².

"The symptoms of PsA and ERA can be debilitating for children and adolescents living with these chronic conditions, impacting their daily lives," said Tiffany Westrich-Robertson, CEO, International Foundation for Autoimmune & Autoinflammatory Arthritis (AiArthritis). "It is encouraging to see an additional treatment option for these underserved patient populations." 

In July 2020, Cosentyx received EU approval as a first-line systemic treatment for pediatric psoriasis in patients aged 6 to less than 18 years and recently received approval in the US and China^1,9,10. In 2021, Cosentyx was also approved in Japan to treat psoriatic arthritis and psoriasis in pediatric patients aged 6 years or older, as well as generalized pustular psoriasis¹¹.

Novartis has filed regulatory submissions for Cosentyx in ERA and JPsA in Europe with a decision anticipated in the coming months.

About Cosentyx^® (secukinumab)
Cosentyx is the first and only fully-human biologic that directly inhibits interleukin-17A (IL-17A), an important cytokine involved in the inflammation of psoriatic arthritis, (PsA), moderate to severe plaque psoriasis, (PsO), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)^12,13. Cosentyx is a proven medicine and has been studied clinically for more than 14 years. The medicine is backed by robust evidence, including five years of clinical data in adults supporting long-term safety and efficacy across moderate to severe PsO, PsA and AS^14-20. These data strengthen the position of Cosentyx as a treatment across AS and nr-axSpA, PsA and moderate to severe PsO, supported by more than 500,000 patients treated worldwide since launch in 2015^1,21,22.

Indications

COSENTYX is a prescription medicine used to treat:

• people 6 years of age and older with moderate to severe plaque psoriasis that involves large areas or many areas of the body, and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light alone or with systemic therapy)
• people 2 years of age and older with active psoriatic arthritis
• adults with active ankylosing spondylitis
• adults with active non-radiographic axial spondyloarthritis (nr-axSpA) and objective signs of inflammation
• people 4 years of age and older with active enthesitis-related arthritis

IMPORTANT SAFETY INFORMATION

Do not use COSENTYX if you have had a severe allergic reaction to secukinumab or any of the other ingredients in COSENTYX. See the Medication Guide for a complete list of ingredients.

COSENTYX is a medicine that affects your immune system. COSENTYX may increase your risk of having serious side effects such as:

Infections

COSENTYX may lower the ability of your immune system to fight infections and may increase your risk of infections, sometimes serious.

• Your doctor should check you for tuberculosis (TB) before starting treatment with COSENTYX.
• If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with COSENTYX and during treatment with COSENTYX.
• Your doctor should watch you closely for signs and symptoms of TB during treatment with COSENTYX. Do not take COSENTYX if you have an active TB infection.

Before starting COSENTYX, tell your doctor if you:

• are being treated for an infection
• have an infection that does not go away or that keeps coming back
• have TB or have been in close contact with someone with TB
• think you have an infection or have symptoms of an infection such as: fevers, sweats, or chills; muscle aches; cough; shortness of breath; blood in your phlegm; weight loss; warm, red, or painful skin or sores on your body; diarrhea or stomach pain; burning when you urinate or urinate more often than normal

After starting COSENTYX, call your doctor right away if you have any signs of infection listed above. Do not use COSENTYX if you have any signs of infection unless you are instructed to by your doctor.

Inflammatory bowel disease

New cases of inflammatory bowel disease or "flare‐ups" can happen with COSENTYX, and can sometimes be serious. If you have inflammatory bowel disease (ulcerative colitis or Crohn's disease), tell your healthcare provider if you have worsening disease symptoms during treatment with COSENTYX or develop new symptoms of stomach pain or diarrhea.

Serious allergic reactions

Serious allergic reactions can occur. Get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction: feel faint; trouble breathing or throat tightness; skin rash; swelling of your face, eyelids, lips, mouth, tongue, or throat; chest tightness; hives (red, itchy bumps). If you have a severe allergic reaction, do not give another injection of COSENTYX.

Before starting COSENTYX, tell your doctor if you:

• have any of the conditions or symptoms listed above for infections.
• have inflammatory bowel disease (Crohn's disease or ulcerative colitis).
• are allergic to latex. The needle cap on the COSENTYX Sensoready^® 150 mg/mL pen, 150 mg/mL and 75 mg/0.5 mL prefilled syringes contains latex.
• have recently received or are scheduled to receive an immunization (vaccine). People who take COSENTYX should not receive live vaccines. Children should be brought up to date with all vaccines before starting COSENTYX.
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if COSENTYX can harm your unborn baby. You and your healthcare provider should decide if you will use COSENTYX.
• are breastfeeding or plan to breastfeed. It is not known if COSENTYX passes into your breast milk.

Tell your doctor about all the medicines you take, including prescription and over‐the‐counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of your medicines to show your doctor and pharmacist when you get a new medicine.

How should I use COSENTYX?

See the detailed "Instructions for Use" that comes with your COSENTYX for information on how to prepare and inject a dose of COSENTYX, and how to properly throw away (dispose of) used COSENTYX Sensoready pen and prefilled syringes.

• Use COSENTYX exactly as prescribed by your doctor.
• If your doctor decides that you or a caregiver may give your injections of COSENTYX at home, you should receive training on the right way to prepare and inject COSENTYX. Do not try to inject COSENTYX yourself, until you or your caregiver has been shown how to inject COSENTYX by your doctor or nurse.

The most common side effects of COSENTYX include: cold symptoms, diarrhea, and upper respiratory infections. These are not all of the possible side effects of COSENTYX. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information, including Medication Guide.

About Novartis

Located in East Hanover, NJ Novartis Pharmaceuticals Corporation – an affiliate of Novartis – is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis employs nearly 15,500 people in the United States. For more information, please visit https://www.novartis.us.

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Julie Masow	Michael Meo
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