The European Commission has approved Almirall’s Ilumetri for moderate-to-severe chronic plaque psoriasis.
Ilumetri (tildrakizumab), a high-affinity humanised monoclonal antibody that inhibits the p19 subunit of IL-23, has been cleared for use in adult patients who are candidates for systemic therapy.
The treatment is administered via subcutaneous injection every three months during maintenance, thus offering patients “greater convenience and quality of life…achieving a better control and improved treatment satisfaction,” according to Almirall.
The approval is based on data from Resurface 1 and 2 trials, in which an average of 63% of patients achieved 75% of skin clearance (Psoriasis Area Sensitivity Index or PASI 75) by week 12 and an average of 78% at week 28 after three doses.
Also, an average of 59% of patients achieved PASI 90 and an average of 30% reached PASI 100 at week 28.
Over the longer term, PASI 75 responses were maintained with continued treatment with Ilumetri in 90% of patients up to week 148, while more than 50% reported that psoriasis no longer affected their lives after just 3 doses.
“Ilumetri is a safe, easy to administer, targeted IL-23p19 inhibitor that provides durable efficacy and long-term safety, this marks a very important milestone for Almirall in the medical dermatology area, specifically in the biological drugs market,” said the firm’s chief executive Peter Guenter.