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LEO Pharma Receives Scientific Approval of Enstilar® for the Treatment of Psoriasis in EU

The marketing approval of Enstilar® would make it the first fixed combination topical foam treatment for people living with psoriasis vulgaris in the EU.

Ballerup, Denmark--(March 18, 2016) - LEO Pharma today announced that it received scientific approval of Enstilar® (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® is an alcohol-free foam formulation for the topical treatment for psoriasis vulgaris.footnote 11

“The scientific approval of Enstilar® 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® 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® was developed to treat patients with psoriasis vulgarisfootnotes 2 and 32,3 – the most common clinical form of psoriasis. In Europe, nearly four million people are living with psoriasis.footnote 55

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® are expected later this year. In October 2015, Enstilar® was approved for use by the U.S. Food and Drug Administration (FDA).

Market authorisation in Canada has not yet been obtained. The safety and efficacy of calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g) foam are still under investigation.

About Enstilar®

Enstilar® 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. 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.footnote 66 Psoriasis is estimated to affect about 2-4% of the population in western countries.footnote 77 80% of patients are affected by psoriasis vulgaris – the most common type of psoriasis.footnote 44 Topical treatments can be used as first-line therapies for the majority of patients suffering from psoriasis.footnotes 88

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 www.leo-pharma.com

References

  1. Enstilar® 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. Mrowietz U, Reich K. Psoriasis – new insights into pathogenesis and treatment. Dtsch Arztebl Int 2009; 106 :11–19
  5. EFPIA Who does psoriasis affect? Available at www.efpia.eu/diseases/134/59/Psoriasis. Last accessed on February 9, 2016.
  6. De Fatima Santos Paim de Oliveiera, M et al. Psoriasis: classical and emerging comorbidities. An Bras Dermatol 2015; 90(1): 9-20
  7. Parisi R, Symmons DP, Griffiths CE, Ashcroft DM; Identification and Management of Psoriasis and Associated ComorbidiTy (IMPACT) project team (February 2013). "Global epidemiology of psoriasis: a systematic review of incidence and prevalence". J Invest Dermatol 133 (2): 377–85
  8. Men. ter A, Korman NJ, Elmets CA et alGuidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol 2009;60: 643–659