LEO Pharma Receives Marketing Authorisation for Kyntheum® (Brodalumab), a New Biologic for the Treatment of Moderate-to-Severe Plaque Psoriasis in the European Union

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Psoriasis is a common, chronic, immune-mediated, inflammatory disease^[4] affecting an estimated 125 million people worldwide,^[5] including nearly 14 million Europeans.^[6] It primarily affects the skin, but carries with it a substantial social and psychological burden, even when a relatively small proportion of body surface is affected.^[4]

Kyntheum^® is different from existing therapies. By specifically binding to the receptor on skin cells rather than targeting free floating inflammatory mediators, brodalumab blocks the biological activity of several pro-inflammatory IL-17 cytokines involved in psoriasis plaque formation.^[2],[7],[8]

"Lasting skin clearance is our ultimate treatment goal for psoriasis patients, as it has such a significant impact on an individual's wider wellbeing, along with their physical health. Experiencing clear skin brings a huge benefit to patients. Results from the AMAGINE trials show that Kyntheum^® has the potential to virtually clear psoriasis in almost 80% of patients, often within just three months^[*], establishing its approval as a major advancement within the field of psoriasis" commented Professor Dr. Ulrich Mrowietz, Psoriasis Centre, University Medical Centre, Schleswig-Holstein, Germany.

The AMAGINE trials - AMAGINE-1-3 - involved 4,373 patients with moderate-to-severe psoriasis,^[9],[10] the largest study population in the development program of any new biologic treatment in psoriasis to date.^{[11],[12],[13],[14],[15],[16],[17]} All three trials evaluated the efficacy and safety of different doses of Kyntheum^® compared to placebo^[9],[10] and AMAGINE-2 and -3 also compared Kyntheum^® to ustekinumab.^[9] Kyntheum^® was well tolerated in all trials with an acceptable safety profile.^[18] Although cases of suicidal ideation and behaviour were reported, no causal association between treatment with Kyntheum^® and increased risk of suicidal ideation and behaviour has been established.^[19] Its launch in Europe will be supported by post-marketing pharmacovigilance activities to capture and follow up on any reports of safety events.

Gitte Pugholm Aabo, President and CEO of LEO Pharma, said: "Those most affected by psoriasis often feel controlled by their condition, the stigma it brings, and the diverse complications associated with it. We hope that the EU approval of Kyntheum^® will help many more people to regain control, and live lives unrestricted by psoriasis, while our role is to support them throughout their journey to clear skin."

Brodalumab is currently approved in the U.S. and Japan for adult patients with moderate-to-severe plaque psoriasis. In Japan, it is also approved for psoriasis vulgaris, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma.

* 76-79% of patients achieved clear or almost clear skin (sPGA scores of 0 or 1) after 3 months of treatment with Kyntheum

-ENDS-

NOTES TO EDITORS   

About Kyntheum^®

Kyntheum^®(brodalumab) is the only fully human monoclonal antibody that selectively targets the IL-17 receptor subunit A.^[2],[3] By binding to the receptor with high affinity, Kyntheum^® effectively blocks the biological activity of several pro-inflammatory IL-17 cytokines, which are important in psoriasis.^[3],[20]

The psoriasis clinical studies programme for Kyntheum^® consisted of three clinical trials; AMAGINE-1 (n=661), AMAGINE-2 (n=1831) and AMAGINE-3 (n=1881).^[9],[10] Results showed Kyntheum^® 210mg offered more patients complete skin clearance (PASI 100) at 12 weeks compared to patients treated with ustekinumab [AMAGINE-2: 44% (n=272) versus 22% (n=65), p<0.001; AMAGINE-3: 37% (n=229) versus 19% (n=58), p<0.001].^[9]

In AMAGINE-1 83% of patients on Kyntheum^® 210mg achieved PASI 75^[†] compared to 3% of patients treated with placebo at 12 weeks [83.3% (n=185) versus 2.7% (n=6), p<0.001] and 76% of patients achieved sPGA^[‡] success versus 1% of patients treated with placebo [75.7% (n=168) versus 1.4% (n=3), p<0.001].^[10]

In the AMAGINE trials more than half (53-56%) of patients on continuous Kyntheum^® treatment achieved PASI 100 at week 52.^[10],[21]

Patients also reported experiencing improved health-related quality of life after four weeks of treatment with Kyntheum^®.^[22] After 12 weeks of treatment, seven in ten patients (72%, n=29/40, p<0.0001) reported psoriasis no longer impaired their health-related quality of life, (0/1 DLQI) compared with placebo (5%, n=2/37).^[22]

Data from the three large randomised, controlled AMAGINE clinical trials, found Kyntheum^® to be well tolerated, with an acceptable safety profile.^[18] The most common adverse events were arthralgia (joint pain), nasopharyngitis (inflammation of the nose and pharynx), headache, and upper respiratory tract infection.^[10]

In July 2016, LEO Pharma entered into a partnership agreement with AstraZeneca granting LEO Pharma exclusive licence to develop and commercialise Kyntheum^® in Europe. Outside of Europe, Valeant Pharmaceuticals has global commercial rights for brodalumab except in Japan and certain other Asian countries, where the rights are held by Kyowa Hakko Kirin Co., Ltd.

† PASI 75 is defined ≥ 75% improvement in Psoriasis Area and Severity Index score

‡ sPGA success is defined as patients who achieved a static Physician's Global Assessment 0 or 1

About psoriasis    

Psoriasis is a common, chronic, immune-mediated, inflammatory disease that primarily involves the skin.^[4] The most frequently reported symptoms include thickening and scaling of the skin, itching and erythema (superficial reddening of the skin, usually in patches).^[4]

An estimated 125 million people worldwide live with psoriasis,^[5] including nearly 14 million Europeans.^[6]

Psoriasis can be a painful, disabling and stigmatising condition with substantial social and psychological impact on a person's life.^[17] People with psoriasis, especially those with more severe symptoms, are also at increased risk of developing other serious associated conditions,^[23] including heart disease^{[24],[25],[26]} and metabolic diseases (a combination of diabetes, high blood pressure and obesity).^[27] Mental health complications, such as depression and anxiety, are also more common in people with psoriasis.^[28]

According to the World Health Organization, the burden of living with psoriasis is underestimated and it urges for action to fight stigma and improve treatment.^[4]

About LEO Pharma   

LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. LEO Pharma offers a comprehensive range of integrated care solutions for control and relief of psoriasis. By expanding its portfolio into biologics, through the approval of Kyntheum^®, the company is set to become the world's leading dermatology company.

Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 5,000 people worldwide.

For more information, visit http://www.leo-pharma.com

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References   

1.    European Commission, Community register of medicinal products for human use, Kyntheum® (brodalumab). Available from:  http://ec.europa.eu/health/documents/community-register/html/h1155.htm (Accessed July 2017)

2.    Campa M, et al. Dermatol Ther. 2016;6:1-12

3.    Coimbra S, et al. Core Evidence. 2014;9:89-97

4.    World Health Organization (WHO). Global Report on Psoriasis. Available from: http://apps.who.int/iris/bitstream/10665/204417/1/9789241565189_eng.pdf  (Accessed July 2017)

5.    The International Federation of Psoriasis Associations. Available at: https://ifpa-pso.com/ (Accessed July 2017)

6.    Ortonne J, et al. Eur J Dermatol. 2004;14:41-45

7.    Beringer A, et al. Trends Mol Med. 2016; 22: 230-41

8.    Russell CB, et al. J Immunol. 2014; 192: 3828-36

9.    Lebwohl M, et al. N Engl J Med 2015;373:1318-28

10.   Papp K, et al. Br J Dermatol. 2016;175:273-286

11.   European Medicines Agency. EPAR summary for the public: Cosentyx. 2015. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-Summary_for_the_public/human/003729/WC500183132.pdf  (Accessed July 2017)

12.   Taltz®. Summary of Product Characteristics 2016. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-Product_Information/human/003943/WC500205804.pdf   (Accessed July 2017)  

13.   Stelara®. Summary of Product Characteristics 2009. Available from: https://www.medicines.org.uk/emc/medicine/32569 (Accessed July 2017)

14.   Enbrel®. Summary of Product Characteristics 2000. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000262/WC500027361.pdf (Accessed July 2017)

15.   Humira®. Summary of Product Charateristics 2003. Available from: https://www.medicines.org.uk/emc/medicine/31860 (Accessed July 2017)

16.   Remicade®. Summary of Product Characteristics 1999. Available from:http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-Product_Information/human/000240/WC500050888.pdf  (Accessed July 2017)

17.   National Institute for Health and Care Excellence (NICE) Psoriasis: assessment and management guidelines. Available at: https://www.nice.org.uk/guidance/cg153/chapter/1-Guidance#systemic-therapy (Accessed July 2017)

18.   Attia A, et al. Clin Drug Investig. 2017; DOI: 10.1007/s40261-017-0500-9

19.   Lebwohl, M. et al. The American Academy of Dermatology annual meeting 2017. Poster 4908

20.   Papp K, et al. N Engl J Med. 2012;336:1181-9

21.   Supplement to: Lebwohl M, et al. N Engl J Med. 2015;373:1318-28

22.   Gordon KB, et al. Br J Dermatol. 2014;170:705-15

23.   Reich K.  Eur Acad Dermatol Venereol. 2012; 26(2):3-11

24.   Gelfand JM, et al. JAMA. 2016;296:1735-41

25.   Ahlehoff O, et al. Eur Heart J. 2012;33:2054-64

26.   Lowes MA, et al. Immunology of psoriasis. Ann Rev Immunol. 2014;32:227-35

27.   Langan SM, et al. J Invest Dermatol. 2012 Mar; 132(3 0 1): 556-562

28.   Dalgard F, et al. JID. 2015;135(4), 984-991