[2][3][5] Tildrakizumab was designed to block interleukin-23 (IL-23), a cytokine that plays a key role in managing the immune system and autoimmune disease.
[6][7] Tildrakizumab was approved by the Food and Drug Administration in March 2018,[2] and the European Medicines Agency in September 2018, for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.
[9] 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.
Through this specific blockage, tildrakizumab inhibits the release of proinflammatory cytokines and chemokines that mediate epidermal hyperplasia, keratinocyte immune activation, and tissue inflammation inherent in psoriasis.
However, compared with the inhibition of other inflammatory cytokines, IL-23 targeting may only minimally impair the ability to generate a proper immune response.
[14][16] Specifically, the incidence of severe infections, malignancies, and major adverse cardiovascular events was low and similar to that of placebo and etanercept treatment groups.
[14] 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.
[5] In September 2018, it was approved by the European Commission for the treatment of adults with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy.