Almirall's Actikerall set for first approvals
This article was originally published in Scrip
Almirall is set to receive its first approvals for Actikerall (5mg/g fluorouracil and 100mg/g salicylic acid) a topical solution for the treatment of actinic keratosis. It has been granted a positive recommendation by regulatory authorities in Germany, the UK, Austria, Luxembourg, Poland, Czech Republic and Slovakia, for the treatment of palpable and/or moderately thick hyperkeratotic actinic keratosis (grade 1/11) in adults.
Its first launches are expected in Germany and the UK in mid 2011, contingent upon final approvals of national packaging and labelling.
Once available Actikerall will compete with other fluorouracil formulations such as Sanofi-Aventis' Carac, Valeant's Efudex and Allergan's Fluoroplex, as well as imiquimod formulations including 3M Pharmaceuticals' Aldara and Graceway Pharmaceuticals' Zyclara. Other treatments include PharmaDerm's Solaraze (diclofenac sodium).
Almirall believes Actikerall will be able to compete because of its clinical performance. Clinical data showed confirmed histological clearance in 72% of patients and a sustained clinical benefit of 85.8% of lesions cleared 12 months post-treatment in those patients. Its safety profile was also favourable, with only mild to moderate application site adverse events reported. Almirall also claims Actikerall is easier to apply than its competitors.
Almirall is considering pursuing approval in other EU countries, but was unable to confirm details. Also to be confirmed, subject to approval procedures and timings, is in which countries Actikerall will launch after the UK and Germany.
Actinic keratoses (or solar keratoses) are very common scaly or crusty pre-cancerous patches on the skin condition caused by sun exposure.