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

Ballerup, Denmark (ots/PRNewswire) -

Opinion from CHMP: "On 18 May 2017, the Committee for Medicinal
Products for Human Use (CHMP) adopted a positive opinion,
recommending the granting of a marketing authorisation for the
medicinal product [brodalumab], intended for the treatment of
psoriasis[...]The benefits with [brodalumab] are its ability to
inhibit the inflammation and clinical symptoms associated with
psoriasis. The most common side effects are arthralgia, headache,
fatigue, diarrhoea, and oropharyngeal pain[...]The full indication
is: [brodalumab] is indicated for the treatment of moderate to severe
plaque psoriasis in adult patients who are candidates for systemic
therapy."

LEO Pharma today announced that it received a positive opinion
from the European Committee for Medicinal Products for Human Use
(CHMP) recommending marketing authorisation for brodalumab, a novel
biologic treatment for adult patients with moderate to severe plaque
psoriasis who are candidates for systemic therapy.[1] 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, brodalumab effectively blocks the biological activity of
several pro-inflammatory IL-17 cytokines, which are important in
psoriasis.[3],[4] Brodalumab is not currently licensed in the EU.

The positive opinion from the CHMP is supported by data from three
clinical trials, AMAGINE-1 (n=661), AMAGINE-2 (n=1831) and AMAGINE-3
(n=1881), with a total of 4,373 patients with moderate to severe
psoriasis;[5],[6] the largest study population of any new biologic
treatment in psoriasis to date.[7],[8],[9],[10],[11],[12],[13] All
three studies evaluated the efficacy and safety of different doses of
brodalumab compared to placebo.[5],[6] AMAGINE-2 and AMAGINE-3 also
compared brodalumab to ustekinumab.[5]

Results showed brodalumab offered many 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].[5]In AMAGINE-1
83% of patients on brodalumab 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].[6] High levels of skin clearance were sustained with
continuous brodalumab treatment through week 52.[6],[14]

"Brodalumab works by blocking the pro-inflammatory cascade that
leads to psoriasis, resulting in normalisation of skin inflammation.
In the brodalumab clinical trials, the majority of patients achieve
clear or almost clear skin within 3 months of treatment as measured
by the psoriasis area and severity index (PASI) 100 or 90. In real
terms, this means that patients get to the point where their
psoriasis no longer bothers them and this is the ultimate treatment
goal," commented Professor Kristian Reich, Dermatologist and
Principal Investigator of the AMAGINE Phase 3 clinical trials
programme for brodalumab, Hamburg, Germany.

Patients also reported experiencing improved health related
quality of life after 4 weeks of treatment with brodalumab. 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).[15]

"It is critical that people with psoriasis have the necessary
tools and support to help them get through life as unhindered by
their condition as possible and don't feel it controls their life. At
LEO Pharma we are committed to improving the lives of people with
skin conditions, and this positive opinion from the CHMP takes us one
step closer to being able to do exactly that for the people who
matter most to us. The evidence for brodalumab demonstrates real
promise and we hope that we can provide not only a new treatment
option, but also the opportunity to help people living with
moderate-to-severe psoriasis to take control of their condition and
improve their lives significantly," says Kim Domela Kjøller,
Executive Vice President of Global Research and Development at LEO
Pharma.

Data from the three large randomised, controlled AMAGINE clinical
trials, found brodalumab to be well tolerated, with an acceptable
safety profile.[6],[16] The most common adverse events were
arthralgia (joint pain), nasopharyngitis (inflammation of the nose
and pharynx), headache, and upper respiratory tract infection.[5]

Cases of suicidal ideation and behaviour, including completed
suicide, were reported in the clinical trials programme.[17] A causal
association between treatment with brodalumab and increased risk of
suicidal ideation and behaviour has not been established.[17]
Brodalumab will be supported by post-marketing pharmacovigilance
activities to capture and follow up on any reports of safety events.

The CHMP's recommendation will now be referred to the European
Commission, which has the authority to approve medicines for use in
all EU countries. This announcement follows the approval of
brodalumab by the U.S. Food and Drug Administration for plaque
psoriasis in February 2017; and the approval by the Japanese
Pharmaceuticals and Medical Devices Agency for psoriasis vulgaris,
psoriatic arthritis, pustular psoriasis and psoriatic erythroderma in
2016.

--------------------------------------------------

*. 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

NOTES TO EDITORS

About Brodalumab

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, brodalumab effectively blocks the
biological activity of several pro-inflammatory IL-17 cytokines,
which are important in psoriasis.[3],[4] Brodalumab is not currently
licensed in the EU.

In July 2016, LEO Pharma entered into a partnership agreement with
AstraZeneca granting LEO exclusive licence to develop and
commercialise brodalumab 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.

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.

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

Subscribe to our YouTube channel:
http://www.youtube.com/leopharmaglobal

Follow us on Twitter: http://www.twitter.com/leohealthyskin

Visit us at LinkedIn: http://www.linkedin.com/company/leo-pharma

About Psoriasis

An estimated 125 million people worldwide live with psoriasis,[18]
including nearly 14 million Europeans.[19] While there are several
types of psoriasis, of which plaque psoriasis is most common
affecting up to 97% of patients, the most frequently reported
symptoms include thickening and scaling of the skin, itching and
erythema (superficial reddening of the skin, usually in patches).[20]

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/003
959/smops/Positive/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_li
brary/EPAR_-_Summary_for_the_public/human/003729/WC500183132.pdf (http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/003729/WC500183132.pdf)
(Accessed May 2017)

8. Taltz®. Summary of Product Characteristics 2016. Available from: h (http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003943/WC500205804.pdf)
ttp://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_In (http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003943/WC500205804.pdf)
formation/human/003943/WC500205804.pdf (http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003943/WC500205804.pdf) (Accessed May 2017)

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

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

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

12. Remicade®. Summary of Product Characteristics 1999. Available
from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Pr
oduct_Information/human/000240/WC500050888.pdf (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 (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/10665/204417/1/978
9241565189_eng.pdf (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

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