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Picato® Gel Receives EU Marketing Authorisation for Treatment of Actinic Keratosis
By: PR Newswire
Nov. 19, 2012 05:44 AM
BALLERUP, Denmark, November 19, 2012 /PRNewswire/ --
Today LEO Pharma announced that the European Commission (EC) has granted marketing authorisation for Picato® (ingenol mebutate) gel as a treatment for actinic keratosis in the European Union (EU). Picato® gel is a once-daily, two or three day field-directed topical treatment for actinic keratosis, a common skin condition which if not treated can lead to squamous cell carcinoma, a form of non-melanoma skin cancer.
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Actinic keratosis can be an under-diagnosed condition, yet the prevalence in adults aged over 40 years ranges between 11-25 per cent in susceptible populations of the northern hemisphere, and between 40-60 per cent in the southern hemisphere. Current topical treatments have long treatment durations that last for periods from one, up to four months, which can lead to low patient adherence.[4-6]
Professor Eggert Stockfleth, Head of Dermatology at the Skin Centre Charité Hospital in Berlin, Germany and Head of the European Skin Cancer Foundation (ESCF), commented:
"Since it is impossible to predict which actinic keratosis lesions will advance to non-melanoma skin cancer, early detection and effective treatment is critical. What makes Picato® gel a particularly appealing product is the short treatment duration needed to treat actinic keratosis. This short duration - just two or three days - should lead to higher patient adherence. In clinical trials adherence was as high as 98 per cent."
Actinic keratoses often appear as red, scaly lesions predominantly seen on skin frequently exposed to the sun, such as the face, head, arms and legs. They can occur as single lesions or multiple lesions affecting an area of skin (a 'field'). Actinic keratoses can lead to squamous cell carcinoma - in fact, research shows 65 per cent of squamous cell carcinomas arise from lesions previously diagnosed as actinic keratoses.
Picato® gel is indicated for the cutaneous treatment of adult patients with non-hyperkeratotic, non-hypertrophic actinic keratosis. Picato® gel treats actinic keratoses over a limited area (field) of sun-damaged skin. Picato® gel is available in two different dosage strengths for treatment of specific areas of the body. For treatment of the face and scalp, Picato® gel is applied at a concentration of 150 mcg/g once daily for three consecutive days. For treatment of the trunk and extremities, the gel is applied at a concentration of 500 mcg/g once daily for two consecutive days.
Gitte P. Aabo, Chief Executive Officer (CEO) of LEO Pharma, commented:
"Actinic keratosis is a growing problem across the world, yet many patients do not recognise their symptoms or the significance of them, unaware that lesions can in some cases develop into non-melanoma skin cancer. Picato® gel requires just two or three consecutive days of treatment, compared to several weeks or months for existing topical therapies. Following approval in the US, the approval of Picato® gel in the EU is another important step in our goal of helping people across the world achieve healthy skin."
Picato® gel was approved by the US Food and Drug Administration (FDA) in January 2012, by the Agência Nacional de Vigilância Sanitária (ANVISA) in Brazil in July 2012 and by the Therapeutic Goods Administration (TGA) in Australia in November 2012.
About Picato® gel
Important product information
About actinic keratoses
About LEO Pharma
- Founded in 1908, LEO Pharma is an independent, research-based pharmaceutical company.
- LEO Pharma develops, manufactures and markets pharmaceutical drugs to dermatologic and thrombotic patients in more than 100 countries globally.
- The company has its own sales forces in 61 countries and employs around 5,000 people worldwide.
- LEO Pharma is headquartered in Denmark and is wholly owned by the LEO Foundation.
- For more information about LEO Pharma, visit http://www.leo-pharma.com.
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