Almirall has received European Commission approval for its plaque psoriasis treatment tildrakizumab (Ilumetri).
Almirall has received European Commission approval for its plaque psoriasis treatment tildrakizumab (Ilumetri), Sun Pharma announced in a press release.
Tildrakizumab, a humanized high-affinity anti-IL-23p19 monoclonal antibody, is indicated for the treatment of adults with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy. Sun Pharma out-licensed tildrakizumab to Almirall for the development and commercialization of the product for psoriasis in Europe.
The drug’s European approval is based on data from the reSURFACE 1 and 3 phase 3 clinical trials, which included 1800 patients from more than 200 clinical sites worldwide and evaluated tildrakizumab’s safety and efficacy.
Psoriasis affects an estimated 7.8 million adults in Europe and approximately 125 million individuals worldwide, according to the release. Plaque psoriasis appears as red, raised areas of skin covered with flaky white scales that can be itchy and painful.
According to the trial data, an average of 63% of patients achieved 75% of skin clearance, measured by the Psoriasis Area Sensitivity Index (PASI) 75 by week 12 and an average of 78% at week 28. An average of 59% of patients achieved PASI 90 and an average of 30% reached PASI 100 at week 28. Over a year, more than 92% of patients who responded to tildrakizumab within 28 weeks maintained a PASI 75 response.
Additionally, the results of a pooled analysis through 3 years from both trials showed the consistent maintenance of efficacy and safety over 3 years of tildrakizumab treatment in patients with moderate-to-severe chronic plaque psoriasis who were responders at week 28. Ninety percent of patients maintained PASI 75 responses with continued treatment with tildrakizumab up to week 148, according to the data.
Tildrakizumab was well-tolerated with very low drug-related serious adverse events and discontinuation rates. Treatment offers an easy and convenient dosing regimen, with only 4 doses per year during maintenance.
With its precise targeting, tildrakizumab has the potential to help control the pathogenic cells responsible for the inflammatory process of psoriasis with limited impact on the rest of the immune system, Sun Pharma said.
Tildrakizumab will be available in Europe within the next few weeks, according to the press release.
This article was originally published at SpecialtyPharmacyTimes.com.
Sun Pharma Announces Receipt of European Commission Approval for ILUMETRI (tildrakizumab) By Almirall For Treatment of Moderate-To-Severe Chronic Plaque Psoriasis [news release]. Sun Pharma’s website. https://www.sunpharma.com/media/press-releases. Accessed September 18, 2018.