European Commission approves Ilumetri to treat psoriasis.- Almirall

Almirall, S.A. has announced that the European Commission (EC) has approved Ilumetri (tildrakizumab), a humanized, high-affinity IL-23p19 monoclonal antibody, for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy. Roll out of Ilumetri (tildrakizumab) in Europe will start in the next few weeks. Germany will be the first country to launch the product.

Tildrakizumab is a humanized high-affinity anti-IL-23p19 monoclonal antibody. Due to its specific mechanism of action, it selectively blocks interleukin-23 (IL-23), an upstream inflammatory mediator cytokine, and acts by modifying the pathogenesis of the disease with limited impact on the rest of the immune system. Tildrakizumab constitutes a very significant step forward in the treatment of moderate-to-severe chronic plaque psoriasis, it is a drug with a high level of safety and efficacy that achieves a long-term control of the disease. Ilumetri (tildrakizumab) is administered by subcutaneous injection. Its convenient dosing regimen, every 3 months during maintenance, results in greater convenience and quality of life for patients, achieving a better control and improved treatment satisfaction. With only 4 doses per year during maintenance, Ilumetri offers a convenient dosing regimen. This low frequency of injections may also encourage adherence. Its approval in Europe is based on reSURFACE 1 and 23 positive results, presented for the first time in October 2016 at the 25th European Academy of Dermatology and Venerology (EADV) Congress in Vienna (Austria). Both pivotal phase III clinical trials, which included over 1,800 patients from more than 200 clinical sites worldwide, showed Ilumetri has a high level of safety and efficacy.

According to both studies data, 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 only three doses. Moreover, 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 Ilumetri within 28 weeks maintained a PASI 75 response. Moreover, the results of a pooled analysis through 3 years from reSURFACE 1 and reSURFACE 2 phase III trials show the consistent maintenance of efficacy and safety over three years of ILumetri in patients with moderate-to-severe chronic plaque psoriasis who were responders at week 28. According to the data, PASI 75 responses were maintained with continued treatment with Ilumetri in 9 out of 10 patients up to week 148. More than 50% of patients reported that psoriasis no longer affected their lives after only 3 doses. Ilumetri was well-tolerated with very low drug-related serious adverse events and discontinuation rates.

Almirall in-licensed tildrakizumab from Sun Pharmaceutical Industries Ltd. in July 2016. The agreement is for development and commercialization of Ilumetri (tildrakizumab) in Europe. Sun Pharma got approval for tildrakizumab from the FDA in March this year for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.