Almirall, S.A. has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the regulatory approval of tildrakizumab, under the brand name ILUMETRI®, an investigational humanised, high-affinity IL-23p19 monoclonal antibody for adults with moderate-to-severe chronic plaque psoriasis.
Tildrakizumab is a cutting-edge biological drug due to its specific mechanism of action. It has been designed to selectively block the p19 subunit of interleukin-23 (IL-23), an upstream inflammatory mediator with regulatory properties and it acts by modifying the pathogenesis of the disease with limited impact on the rest of the immune system.
Tildrakizumab is the result of the licensing agreement reached between Almirall and Sun Pharma for the development and commercialisation of this therapy for psoriasis in Europe. Last March, Sun Pharma received the Food and Drug Administration (FDA) approval for tildrakizumab in the United States for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The CHMP positive opinion is based on reSURFACE 1 and 21 positive results, presented for the first time in October 2016 at the 25th European Academy of Dermatology and Venerology (EADV) Congress. Those pivotal phase III clinical trials, which included over 1,800 patients from more than 200 clinical sites worldwide, showed that tildrakizumab has a high level of safety and efficacy.
According to both studies, after only three doses eight out of ten patients treated with tildrakizumab 100 mg or 200 mg achieved 75% of skin clearance (Psoriasis Area Severity Index or PASI 75) at week 28. Over a year, more than 90% of patients who responded to tildrakizumab within 28 weeks maintained a PASI 75 response.
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.
Peter Guenter, Almirall’s CEO commented, “We are proud of the positive recommendation announced by the CHMP for tildrakizumab as this marks our entry into the biological drugs market. It is a new milestone to consolidate our leading position in medical dermatology and our focus on improving lives by reducing the burden of disease in patients with psoriasis.”