FDA Approves New Plaque Psoriasis Treatment

psoriasis

The FDA approved tildrakizumab-asmn (Ilumyatm) for the treatment of moderate to severe plaque psoriasis among adult patients who are candidates for systemic therapy or phototherapy.

Tildrakizumab-asmn is administered subcutaneously at a dose of 100 mg every 12 weeks after the completion of 2 initial doses at weeks 0 and 4. It selectively binds to the p19 subunit of Interleukin 23 (IL-23), which inhibits its interaction with the IL-23 receptor that leads to the inhibition of the release of pro-inflammatory cytokines and chemokines.
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Approval for tildrakizumab-asmn was based on data from 2 phase 3 multicenter, randomized, double-blind, placebo-controlled trials, which included 926 participants with plaque psoriasis. In both studies, tildrakizumab-asmn met the primary efficacy endpoints.

Adverse effects association with tildrakizumab-asmn included upper respiratory infections, injection site reactions, and diarrhea. Some participants in the clinical trials experienced angioedema and urticarial.

In addition, tildrakizumab-asmn is contradicted for patients who have experienced a previous hypersensitivity reaction to tildrakizumab or any of the excipients. Patients with a clinically important active infection should not initiate treatment with tildrakizumab-asmn until the infection is resolved.