Spanish drugmaker Almirall has launched its skin drug Actikerall in the UK for the treatment of the common disorder actinic keratosis in adults, after receiving the all-clear from regulators.

The move follows a green light from the UK's Medicines and Healthcare products Regulatory Agency, which gave the nod for Actikerall (fluorouracil/salicylic acid) to be used in the treatment of patients with palpable and/or moderately thick hyperkeratotic actinic keratosis (grade I/II). 

Actinic keratosis is characterised by the presence of thick, scaly, or crusty patches on the skin, caused by prolonged exposure to ultraviolet (UV) from sunlight. 

It is estimated that up to one in four adults in the UK currently suffer from at least one Actinic keratosis lesion, which are considered precancerous as they have the potential to lead to invasive squamous cell carcinoma. 

To date, treatment of the condition has involved local procedures such as cryotherapy, laser, and surgical excision, or topical and photodynamic therapies for larger areas.

Performed well in trials

According to Almirall, its new product is an easy-to-use topical solution that, in clinical trials, was able to completely clear skin lesions in 72% of patients after 12 weeks of treatment.

Moreover, this effect was maintained for 12 months in 85.8% of lesions cleared by the drug, which also seemed to be well-tolerated in trials, the firm noted.

Actikerall's NHS list price is £38.30 for a 25ml bottle, which is sufficient for the treatment duration, a spokesperson for the company told PharmaTimes UK News.