title: The European Medicines Agency approval of ingenol mebutate (Picato) for the cutaneous treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis in adults: summary of the scientific assessment of the Committee for Medicinal Products for Human Use (CHMP).
abstract: BACKGROUND
  The European Commission has recently issued a marketing authorisation valid throughout the European Union for ingenol mebutate (Picato) in the cutaneous treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis in adults.
  
  
  OBJECTIVE
  The objective of this paper is to summarise the scientific review of the application leading to regulatory approval in the EU. The full scientific assessment report and product information, including the summary of product characteristics, are available on the EMA website (www.ema.europa.eu).
  
  
  METHODS
  The application was supported by 25 clinical studies, of which 18 were performed in patients with actinic keratosis.
  
  
  RESULTS
  The active substance is a pure ingenol angelate obtained from the aerial parts of the plant species Euphorbia peplus by extraction and purification. One tube of ingenol mebutate 150 mcg/g gel or 500 mcg/g gel should be applied once daily to the affected area for 3 or 2 consecutive days on the 'face and scalp' or 'trunk and extremities', respectively. Complete response rate is 42.2% on the 'face and scalp' and 34.1% on the 'trunk and extremities'. The most common side effects are local skin responses including erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation and erosion/ulceration at the application site.
  
  
  CONCLUSIONS
  The benefits of ingenol mebutate are its ability to improve the complete response rate of actinic keratosis, the short duration of treatment and the ease of self-application.
authors.affiliation: European Medicines Agency, 7 Westferry Circus, London, E14 4HB, UK.
authors.forename: Kyriaki
authors.initials: K
authors.lastname: Tzogani
authors.affiliation: Medicines and Healthcare products Regulatory Agency, London, United Kingdom.
authors.forename: Nithyanandan
authors.initials: N
authors.lastname: Nagercoil
authors.affiliation: Medicines and Healthcare products Regulatory Agency, London, United Kingdom.
authors.forename: Robert James
authors.initials: RJ
authors.lastname: Hemmings
authors.affiliation: Agence Française de Sécurité Sanitaire des Produits de Santé, Saint-Denis, France.
authors.forename: Bekkai
authors.initials: B
authors.lastname: Samir
authors.affiliation: Agence Française de Sécurité Sanitaire des Produits de Santé, Saint-Denis, France.
authors.forename: Jean
authors.initials: J
authors.lastname: Gardette
authors.affiliation: Agence Française de Sécurité Sanitaire des Produits de Santé, Saint-Denis, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Demolis
authors.affiliation: Läkemedelsverket, Medicinal Products Agency, Uppsala.
authors.forename: Tomas
authors.initials: T
authors.lastname: Salmonson
authors.affiliation: European Medicines Agency, 7 Westferry Circus, London, E14 4HB, UK.
authors.forename: Francesco
authors.initials: F
authors.lastname: Pignatti
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000818:Animals; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D003879:Dermatologic Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D004224:Diterpenes / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D017277:Drug Approval; D004890:Erythema / Q000139:chemically induced; D005062:European Union; D005260:Female; D005782:Gels; D006801:Humans; D055623:Keratosis, Actinic / Q000188:drug therapy*; D008297:Male; D018570:Risk Assessment
chemical_list: C486592:3-ingenyl angelate; D000970:Antineoplastic Agents; D003879:Dermatologic Agents; D004224:Diterpenes; D005782:Gels
keywords: EMA; actinic keratosis; ingenol mebutate (Picato)