From the Wires
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.
1. Cohen JL. Actinic keratosis treatment as a key component of preventive strategies for nonmelanoma skin cancer. J Clin Aesthet Dermatol. Jun 2010;3(6):39-44.
2. Naldi L, Chatenoud L, Piccitto R, Colombo P, Placchesi EB, La Vecchia C. Prevalence of actinic keratoses and associated factors in a representative sample of the Italian adult population: Results from the Prevalence of Actinic Keratoses Italian Study, 2003-2004. Arch Dermatol. Jun 2006;142(6):722-726.
3. Frost CA, Green AC. Epidemiology of solar keratoses. Br J Dermatol. Oct 1994;131(4):455-464.
4. Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic keratosis. N Engl J Med. Mar 15 2012;366(11):1010-1019.
5. Shoimer I, Rosen N, Muhn C. Current management of actinic keratoses. Skin therapy letter. May 2010;15(5):5-7.
6. Yentzer B, Hick J, Williams L, et al. Adherence to a topical regimen of 5-fluorouracil, 0.5%, cream for the treatment of actinic keratoses. Arch Dermatol. Feb 2009;145(2):203-205.
7. Stockfleth E, Kerl H. Guidelines for the management of actinic keratoses. Eur J Dermatol. Nov-Dec 2006;16(6):599-606.
8. Criscione VD, Weinstock MA, Naylor MF, et al. Actinic keratoses: Natural history and risk of malignant transformation in the Veterans Affairs Topical Tretinoin Chemoprevention Trial. Cancer. Jun 1 2009;115(11):2523-2530.
9. Cozzi SJ, Ogbourne SM, James C, et al. Ingenol mebutate field-directed treatment of UVB-damaged skin reduces lesion formation and removes mutant p53 patches. J Invest Dermatol. Apr 2012;132(4):1263-1271.
10. Ogbourne SM, Suhrbier A, Jones B, et al. Antitumor activity of 3-ingenyl angelate: plasma membrane and mitochondrial disruption and necrotic cell death. Cancer Res. Apr 15 2004;64(8):2833-2839.
11. Ulrich M, Drecoll U, Stockfleth E. Emerging drugs for actinic keratosis. Expert Opin Emerg Drugs. Dec 2010;15(4):545-555.
12. Harvey I, Frankel S, Marks R, Shalom D, Nolan-Farrell M. Non-melanoma skin cancer and solar keratoses. I. Methods and descriptive results of the South Wales Skin Cancer Study. Br J Cancer. Oct 1996;74(8):1302-1307.
13. Memon AA, Tomenson JA, Bothwell J, Friedmann PS. Prevalence of solar damage and actinic keratosis in a Merseyside population. Br J Dermatol. Jun 2000;142(6):1154-1159.
14. Euvrard S, Kanitakis J, Claudy A. Skin cancers after organ transplantation. N Engl J Med. Apr 24 2003;348(17):1681-1691.
15. Mittelbronn MA, Mullins DL, Ramos-Caro FA, Flowers FP. Frequency of pre-existing actinic keratosis in cutaneous squamous cell carcinoma. Int J Dermatol. Sep 1998;37(9):677-681.
16. Berman B, Amini S, Valins W, Block S. Pharmacotherapy of actinic keratosis. Expert Opin Pharmacother. Dec 2009;10(18):3015-3031.
17. Dodson JM, DeSpain J, Hewett JE, Clark DP. Malignant potential of actinic keratoses and the controversy over treatment. A patient-oriented perspective. Arch Dermatol. Jul 1991;127(7):1029-1031.
18. Salasche SJ. Epidemiology of actinic keratoses and squamous cell carcinoma. J Am Acad Dermatol. Jan 2000;42(1 Pt 2):4-7.
19. Stockfleth E. Topical management of actinic keratosis and field cancerisation. G Ital Dermatol Venereol. Aug 2009;144(4):459-462.
20. Chen GJ, Feldman SR, Williford PM, et al. Clinical diagnosis of actinic keratosis identifies an elderly population at high risk of developing skin cancer. Dermatol Surg. Jan 2005;31(1):43-47.
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