COMUNICADO: Brodalumab, a Novel Biologic for People with Moderate-to-Severe Psoriasis, Receives Positive Opinion from European CHMP

 

COMUNICADO: Brodalumab, a Novel Biologic for People with Moderate-to-Severe Psoriasis, Receives Positive Opinion from European CHMP

Publicado 19/05/2017 18:09:28CET

Psoriasis can be a painful, disabling and stigmatising condition with substantial social and psychological impact on a person's life.[20] Although the systemic nature of psoriasis often remains unrecognised, the inflammatory processes involved may be associated with the development of comorbidities[21] such as cardiovascular and metabolic diseases which are more prevalent in people with moderate-to-severe psoriasis.[22],[23] Research shows that people with moderate-to-severe psoriasis have a two to three-fold risk of anxiety, depression and suicidal behaviour compared to the general public.[24] 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.[20]

References 

1. European Medicines Agency, 18 May 2017. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003959/smops/P ositive/human_smop_001146.jsp&mid=WC0b01ac058001d127     2. Campa M, et al. Dermatol Ther. 2016;6:1-12    3. Coimbra S, et al. Core Evidence. 2014;9:89-97    4. Papp K, et al. N Engl J Med 2012;336:1181-9    5. Lebwohl M, et al. N Engl J Med 2015;373:1318-28    6. Papp K, et al. Br J Dermatol. 2016;175:273-286     7. 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 May 2017)    8. Taltz(R). 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 May 2017)    9. Stelara(R). Summary of Product Characteristics 2009. Available from: https://www.medicines.org.uk/emc/medicine/32569 (Accessed May 2017)    10. Enbrel(R). 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 May 2017)    11. Humira(R). Summary of Product Charateristics 2003. Available from: https://www.medicines.org.uk/emc/medicine/31860 (Accessed May 2017)    12. Remicade(R). 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 May 2017)   13. 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 May 2017)   14. Supplement to: Lebwohl M, et al. N Engl J Med. 2015;373:1318-28   15. Gordon KB, et al. Br J Dermatol. 2014;170:705-15    16. Attia A, et al. Clin Drug Investig. 2017; DOI: 10.1007/s40261-017-0500-9    17. Lebwohl, M. et al. The American Academy of Dermatology annual meeting 2017. Poster 4908   18. The International Federation of Psoriasis Associations. World Psoriasis Day. Available from: https://ifpa-pso.com/our-actions/world-psoriasis-day  (Accessed May 2017) 19. Ortonne J, et al. Eur J Dermatol. 2004;14:41-45   20. World Health Organization (WHO). Global Report on Psoriasis. Available from: http://apps.who.int/iris/bitstream/10665/204417/1/9789241565189_eng.pdf  (Accessed May 2017)   21. Reich K.  Eur Acad Dermatol Venereol. 2012; 26(2):3-11   22. Kimball AB, et al. Br J Dermatol. 2014;171(1):137-147   23. Feldman S, et al. J Man Care and Specialty Pharm. 2015;21(10):874-888  24. Dalgard F, et al. JID. 2015;135(4), 984-991 

CONTACT: Global media contacts: Henrik Steen Hestkjær Kyndlev, GlobalCommunications Manager, Email: HDTDK@leo-pharma.com, Mobile: +45 31406180. Marie Schleimann Nordlund, Snr Global Patient Communication Manager,Email: marie.nordlund@leo-pharma.com, Mobile: +45 3126 3734. Eva JuulLanglands, Corporate Communications Manager, ejldk@lei-pharma.com, Mobile:+45 4188 3094. UK/IE media contacts, Charlotte Murrain, Communications andExternal Affairs Manager Email: CQMUK@leo-pharma.com, Mobile: +44 7557 436771. Julie Wong, Head of Communications, JWGUK@leo-pharma.com, Mobile: +447825 918 989.

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