The European Commission (EC) approved Almirall’s oral dimethyl fumarate (DMF) drug Skilarence® as first-line induction and maintenance therapy for adults with moderate-to-severe plaque psoriasis. The firm said it plans to start marketing the drug in all EU member states, Iceland, and Norway during the third quarter of 2017
Spanish firm Almirall said Skilarence is the first fumaric acid ester (FAE) approved by the EC for treating psoriasis. Regulatory clearance was based on data from the placebo-controlled Phase III BRIDGE study comparing the efficacy and safety of the oral drug Skilarence with the oral FAE drug Fumaderm®, which is approved in Germany but not across Europe.
Fumaric acid esters are a recommended oral systemic therapy for psoriasis and recommended in the European guidelines for induction and long-term maintenance therapy. Commenting on approval of Skilarence in Europe, Eduardo Sanchiz, Almirall's CEO, said “The EC's approval is very good news for healthcare professionals and for a large number of European patients, who will have access to a new therapeutic option for the systemic treatment of moderate-to-severe psoriasis. Skilarence is the result of Almirall's commitment to innovation, and making it available to doctors and their patients with psoriasis will constitute a very important step in reinforcing the company's position as significant player in the field of dermatology”.
Almirall’s dermatology portfolio accounted for 51% of its total €764.4 million (approximately $863 million) net sales in 2016. Dermatology sales during 2016 were up 32.1%, at €390 million (approximately $440 million).
Last month the firm established a collaboration with Leo Pharma to develop a painless, minimally invasive skin sampling method to aid biomarker analysis in research and clinical trials.