HURLEY, England, April 26, 2016 /PRNewswire/ --
Licence marks first combination foam spray for plaque psoriasis: Enstilar® (calcipotriol/betamethasone dipropionate) 50 micrograms/g + 0.5mg/g cutaneous foam
LEO Pharma today announced that it has received Marketing Authorisation (MA) for Enstilar® for the topical treatment of plaque psoriasis in patients 18 years of age or older in the UK.[1]
The application for MA licence was based on on the pivotal Phase 3a PSO-FAST study[2], which evaluated the efficacy and safety profile across a four week period versus placebo, and a Phase 2 MUSE safety profile study[3]. In the PSO-FAST clinical trial, over half (53.3%) of patients treated with Enstilar® were "Clear" or "Almost Clear" by Week 4 as measured by the Physician's Global Assessment (PGA) improvement score, compared to 4.8% in the placebo arm of the study.[2] Additionally, more than half of patients treated with Enstilar® achieved a 75% improvement in Psoriasis Area and Severity Index (PASI) score from baseline.[2]
"Receiving Marketing Authorisation for Enstilar® is a great step forward for people living with psoriasis and LEO Pharma," comments Geraldine Murphy, Managing Director of LEO Pharma UK and Ireland. "Due to the innovative foam spray delivery, Enstilar® is easy-to-apply and a offers a convenient, effective and generally well-tolerated new treatment option for people living with plaque psoriasis in the UK."[3],[4]
Enstilar® was developed to treat patients with plaque psoriasis[1] - the most common clinical form of psoriasis.[5] In the UK, around 1.8 million people have psoriasis.[6]
Data shows that Enstilar® is an effective topical combination (calcipotriol/betamethasone dipropionate) treatment and is generally well-tolerated[3], with some patients in clinical trials experiencing visible signs of improvement within the first week, and more than half achieving treatment success after a four-week period.[2]
Marketing Authorisation is anticipated in the other European countries involved in this regulatory procedure, including Ireland.
Notes to editors
About Enstilar®
Enstilar® (calcipotriol/betamethasone dipropionate) is a topical, alcohol-free, foam spray treatment for all severities of plaque psoriasis in patients who are 18 years or older.[1] It is designed to provide patients with a convenient treatment option that can be easily applied.[4] In clinical trials, the foam spray was generally well-tolerated and provided relief from psoriasis symptoms, including itch.[2],[3] Patients treated with the new product in clinical trials experienced visible signs of improvement within the first week, and more than half achieving treatment success after a four-week period.[2]
About Psoriasis
Psoriasis is a chronic, inflammatory skin disease, which is frequently accompanied by multiple physical and/or psychological comorbidities, such as psoriatic arthritis, diabetes, cardiovascular disease and depression.[7]
Psoriasis is estimated to affect up to 3% of the population of the UK.[6] 80% of patients are affected by plaque psoriasis - the most common type of psoriasis.[5]
Topical treatments can be used as first-line therapies for the majority of patients with psoriasis.[8]
- For more information about psoriasis visit our QualityCare[TM] website at: http://www.qualitycarebyleo.co.uk
- For practical advice to make small changes that can have a big impact on psoriasis, download the MyPso app at the Apple App Store or Google Play
About LEO Pharma
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, the company supports people in managing their skin conditions.
Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to delivering products and solutions to people suffering from skin diseases.
LEO Pharma is headquartered in Denmark and employs around 4,800 people worldwide. The UK/IE affiliate is headquartered in Hurley, Berkshire.
For more information about LEO Pharma UK/IE, visit http://www.leo-pharma.co.uk.
References
- Enstilar® SmPC; UK Available http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1461299716483.pdf. Last Accessed April 2016
- Leonardi C, et al. Efficacy and Safety of Calcipotriene Plus Betamethasone Dipropionate Aerosol Foam in Patients With Psoriasis Vulgaris - a Randomized Phase III Study (PSO-FAST). Journal of Drugs in Dermatology 2015; 14:12
- Taraska V, et al. A Novel Aerosol Foam Formulation of Calcipotriol and Betamethasone Has No Impact on HPA Axis and Calcium Homeostasis in Patients With Extensive Psoriasis Vulgaris. Journal of Cutaneous Medicine and Surgery 2015; 1-8
- Koo J, et al. Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris - A randomized phase II study. Journal of Dermatological Treatment 2015; 1471-1753
- American Academy of Dermatology. Psoriasis. Available https://www.aad.org/media/stats/conditions/psoriasis. Last accessed April 2016
- Psoriasis Association. About Psoriasis. Available https://www.psoriasis-association.org.uk/pages/view/about-psoriasis. Last accessed April 2016
- National Psoriasis Foundation. Comorbidities associatied with psoriatic disease. Available https://www.psoriasis.org/about-psoriasis/related-conditions. Last accessed April 2016
- Psoriasis Assocation. Topical Treatments. Available https://www.psoriasis-association.org.uk/pages/view/about-psoriasis/treatments/first-line-treatments. Last accessed April 2016
Date of preparation: April 2016
Job code: 1070/00036c
