The regulatory filing of investigational IL-23p19 inhibitor tildrakizumab with the European Medicines Agency (EMA) was validated last week, according to Almirall and Sun Pharmaceutical Industries.
Tildrakizumab is being evaluated for treating moderate-to-severe plaque psoriasis, which can be a painful and disfiguring condition. Approximately 7.5 million in the U.S. and 125 million worldwide are affected by the chronic immune disease.
"The filing of tildrakizumab in Europe is a significant step forward for healthcare providers as many patients are still suffering from the disease," Almirall CEO Eduardo Sanchiz said. "Tildrakizumab adds a novel biologic treatment option to our extensive and innovative portfolio, strengthening our position as a leading Dermatology player."
The Phase III clinical trials included in the filing had more than 1,800 participants. The studies, reSURFACE 1 and 2, evaluated tildrakizumab's effectiveness as well as its efficacy and safety.
"Not all people living with psoriasis achieve long-term systemic control with currently available treatments, there are those who continue to struggle every day with the chronic nature of psoriasis," Sun Pharma Executive Vice President of Biologics and Dermatology Jesper Jensen said. "The European filing of tildrakizumab is the next step in our effort to bring a new treatment option to people suffering from psoriasis.”