Tildrakizumab

Tildrakizumab (trade name Ilumya (USA)/Ilumetri (European Union)) is a monoclonal antibody designed for the treatment of immunologically mediated inflammatory disorders. In the United States, it is approved for the treatment of moderate-to-severe plaque psoriasis. Tildrakizumab (trade name Ilumya (USA)/Ilumetri (European Union)) is a monoclonal antibody designed for the treatment of immunologically mediated inflammatory disorders. In the United States, it is approved for the treatment of moderate-to-severe plaque psoriasis. Tildrakizumab was designed to block interleukin-23, a cytokine that plays an important role in managing the immune system and autoimmune disease. Originally developed by Schering-Plough, this drug became part of Merck's clinical program, following that company's acquisition of Schering-Plough. In September 2014 Sun Pharmaceutical acquired worldwide rights to tildrakizumab for use in all human indications from Merck in exchange for an upfront payment of US$80 million. Upon product approval, Sun Pharmaceutical will be responsible for regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product. As of March 2014, the drug was in phase III clinical trials for plaque psoriasis. The two trials enrolled nearly 2000 patients. In 2016, tildrakizumab became the first IL-23p19 inhibitor to demonstrate positive results in Phase-3 clinical trials for the treatment of moderate-to-severe plaque psoriasis, further validating the importance of the role of IL-23 in psoriasis. Sun Pharma signed a licensing pact with Spain's Almirall for marketing tildrakizumab in Europe. In March 2018, it was approved by the Food and Drug Administration for the treatment of moderate-to-severe plaque psoriasis as an injection for subcutaneous use in the United States.In September 2018, it was approved by the European Commission for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy.