The European Commission (EC) approved Almiralls 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 <\/p>\n
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. <\/p>\n
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\". <\/p>\n
Almiralls 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). <\/p>\n
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. <\/p>\n
<\/p>\n
The rest is here: <\/p>\n
Almirall Wins EC Nod for Oral DMF Psoriasis Drug Skilarence - Genetic Engineering & Biotechnology News (press release)<\/a><\/p>\n","protected":false},"excerpt":{"rendered":" The European Commission (EC) approved Almiralls oral dimethyl fumarate (DMF) drug Skilarence as first-line induction and maintenance therapy for adults with moderate-to-severe plaque psoriasis. Continue reading