Shots:
- The US FDA has accepted sBLA of Ilumya (tildrakizumab-asmn) for the treatment of adults with active psoriatic arthritis (PsA), with PDUFA target action date of Oct 29, 2026
- sBLA was backed by P-III (INSPIRE-1 & INSPIRE-2) trials assessing Ilumya (100mg) in pts with PsA over 52wks., where INSPIRE-1 enrolled pts with prior anti-TNF exposure & INSPIRE-2 enrolled anti-TNF naïve pts
- ILUMYA (tildrakizumab-asmn) is a humanized IgG1/k monoclonal antibody that selectively binds the IL-23 p19 subunit, blocking its receptor interaction & inhibiting the release of pro-inflammatory cytokines & chemokines
Ref: PRnewswire | Image: Sun Pharma | Press Release
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