Kyntheum approved in the EU for the treatment of adults with moderate-to-severe plaque psoriasis

Kyntheum is the first and only fully-human monoclonal antibody that selectively targets the IL-17 receptor subunit A on skin cells

20 July 2017

AstraZeneca and MedImmune, its global biologics research and development arm, today announced that its partner LEO Pharma has been granted full marketing authorisation in all 28 EU member countries plus Iceland, Liechtenstein and Norway for Kyntheum (brodalumab), a new biologic medicine developed for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.¹ Kyntheum is the first and only biologic that selectively targets the IL-17 receptor subunit A.^2,3

By binding to this specific receptor subunit on the cells of the skin, rather than targeting free inflammatory mediators, Kyntheum blocks the biological activity of several pro-inflammatory IL-17 cytokines involved in plaque formation.^2,4,5

Psoriasis is a common, chronic, immune-mediated inflammatory skin disease affecting an estimated 125 million people worldwide, including nearly 14 million Europeans.^6,7,8 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

The AMAGINE clinical trial programme (AMAGINE 1-3) involved 4,373 patients with moderate-to-severe psoriasis, the largest study population in the development programme of any new biologic medicine for psoriasis to date.^9-17

In July 2016, AstraZeneca announced an agreement granting LEO Pharma, a specialist in dermatology, exclusive rights 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. Brodalumab is currently approved in the US (under the brand name Siliq) and in Japan for adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

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.^3,7

The psoriasis clinical trials programme for Kyntheum consisted of three clinical trials; AMAGINE-1 (661 patients), AMAGINE-2 (1831 patients) and AMAGINE-3 (1881 patients).^11,12 Results showed Kyntheum 210mg offered many patients complete skin clearance (Psoriasis Area Severity Index [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].¹¹

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].¹²

Data from the three, large, randomised, controlled AMAGINE clinical trials found Kyntheum to be well tolerated, with an acceptable safety profile. The most common adverse events were arthralgia (joint pain), nasopharyngitis (inflammation of the nose and pharynx), headache, and upper respiratory tract infection.¹² 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. Kyntheum’s launch in Europe will be supported by post-marketing pharmacovigilance activities to capture and follow up on any reports of safety events.

* PASI 75 is defined as ≥ 75% improvement in Psoriasis Area 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 skin disease.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, including nearly 14 million Europeans.^5,6

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.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.

CONTACTS

References

1. European Medicines Agency, 19 July 2017: http://ec.europa.eu/health/documents/community-register/html/h1155.htm

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

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

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

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

6. 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)

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

8. Ortonne J, et al. Eur J Dermatol. 2004;14:41–45

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)