The marketing approval of Enstilar(R) would make it the first fixed combination topical foam treatment for people living with psoriasis vulgaris in the EU.
LEO Pharma today announced that it received scientific approval of Enstilar(R) (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g) for the treatment of psoriasis vulgaris in patients 18 years of age or older. Enstilar(R) is an alcohol-free foam formulation for the topical treatment for psoriasis vulgaris.[1]
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"The scientific approval of Enstilar(R) is exciting news, not only for LEO Pharma but also for the millions of Europeans living with psoriasis," said Gitte Aabo, President and CEO of LEO Pharma. "Enstilar(R) is a first-of-its-kind topical spray foam and we believe it will help people living with psoriasis by providing a new type of treatment option that they are looking for."
Enstilar(R) was developed to treat patients with psoriasis vulgaris[2],[3] - the most common clinical form of psoriasis.[4] In Europe, nearly four million people are living with psoriasis.[5]
The application in the EU decentralized procedure for Enstilar(R) was based on the pivotal Phase 3a PSO-FAST study which evaluated the efficacy and safety profile across a four week period,[5] and the Phase 2 MUSE safety profile study.[6] In the PSO-FAST clinical trial, over half of patients treated with Enstilar(R) were "Clear" or "Almost Clear" by Week 4 as measured by the Investigator Global Assessment (IGA) improvement score.[1] Additionally, more than half of patients treated with Enstilar(R) achieved a 75% improvement in Psoriasis Area and Severity Index (PASI) score from baseline.[7]
The scientific approval means that LEO Pharma has received a positive outcome of the decentralized procedure. Receiving this positive outcome is the final step before national marketing authorisations can be granted by the 30 EU countries which are part of the procedure. The national approvals of Enstilar(R) are expected later this year. In October 2015, Enstilar(R) was approved for use by the U.S. Food and Drug Administration (FDA).
About Enstilar(R)
Enstilar(R) is a novel topical spray foam treatment for psoriasis that is designed to provide patients with a convenient treatment option that can be easily applied. In clinical trials, Enstilar(R) was well-tolerated and provided fast relief from psoriasis symptoms. Patients treated with Enstilar(R) in clinical trials experienced significant improvements in symptoms within the first week and more than half achieved treatment success after four weeks.
About Psoriasis
Psoriasis is a chronic, inflammatory skin disease, which is frequently accompanied by multiple physical and/or psychological comorbidities, such as metabolic syndrome and psoriatic arthritis.[6]
Psoriasis is estimated to affect about 2-4% of the population in western countries.[8] 80% of patients are affected by psoriasis vulgaris - the most common type of psoriasis.[4]
Topical treatments can be used as first-line therapies for the majority of patients suffering from psoriasis.[4]
For more information about psoriasis visit our QualityCare (TM) website at: http://www.qualitycarebyleo.co.uk.
About LEO Pharma A/S
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 4,800 people worldwide.
For more information about LEO Pharma, visit http://www.leo-pharma.com
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References
1. Enstilar(R) SmPC; 2016
2. Hollesen Basse L, et al. Enhanced in vitro skin penetration and antipsoriatic effect of fixed combination calcipotriol plus betamethasone dipropionate in an innovative foam vehicle. Journal of Investigative Dermatology 2014; 134(S30): abstract 192
3. Queille-Roussel C, et al. Antipsoriatic effect of a novel aerosol foam formulation of the fixed combination calcipotriene plus betamethasone dipropionate in patients with psoriasis, using a modified psoriasis plaque test. Presented at the Fall Clinical Dermatology Conference, Encore, Las Vegas, October 16-19, 2014
4. Reich K, et al. Efficacy of a fixed combination of with calcipotriol/betamethasone dipropionate topical gel in adult patients with mild to moderate psoriasis: blinded interim analysis of a phase IV, multicentre, randomized, controlled, prospective study. Journal of European Academy of Dermatology Venereology 2014: October (epub ahead of print) DOI: 10.1111/jdv.12774
5. EFPIA Who does psoriasis affect? Available at http://www.efpia.eu/diseases/134/59/Psoriasis. Last accessed on February 9, 2016.
6. LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris. 2013. ClinicalTrials.gov Identifier: NCT01866163.
7. Taraska V, et al. Fixed combination aerosol foam calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD) exhibits no impact on the HPA axis and calcium homeostasis in patients with extensive psoriasis vulgaris: a multicenter, single-arm, Phase II, 4-week MUSE study. Presented at the Skin Disease Education Foundation's 15th Annual Las Vegas Dermatology Seminar & the 11th Annual SDEF Psoriasis Forum, October 30-November 1, 2014
8. Parisi R, et al. Global Epidemiology of Psoriasis: A Systematic Review of Incidence and Prevalence. The Society for Investigative Dermatology. J Invest Dermatol 2013;133(2) :377-85
Global Media Contacts
James Freeman
Global Patient Communications
LEO Pharma A/S
[email protected]
Tel: +45-3166-3637
Source: LEO Pharma A/S
LEO Pharma is a significant step closer to realising its vision of becoming the preferred dermatology care partner following a strategic partnership with AstraZeneca announced today. (Logo: http://photos.prnewswire.com/prnh/20130221/595427 ) The partnership covers potential new medicines for atopic dermatitis and psoriasis, two of the world's major skin diseases where a significant unmet medical need remains. With the partnership, LEO Pharma enters into biological medicines within dermatology