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Eli Lilly Reports the US FDA Approval for Olumiant to Treat Severe Alopecia Areata in Pediatric Patients

Shots:

  • The US FDA has approved Olumiant (baricitinib) for the treatment of pediatric pts (≥12yrs.) with severe alopecia areata (AA), expanding its use from treating adults with mod. to sev. active rheumatoid arthritis & sev. AA
  • Approval was based on 36wk. data from the adolescent cohort (12 to <18yrs.) of P-III (BRAVE-AA-PEDS) study assessing Olumiant (4 or 2mg, PO, QD) vs PBO in pts with sev. AA
  • Trial at 36wks. showed 42% (4mg) & 27% (2mg) pts achieved ≥80% scalp coverage (SALT score ≤20) vs 5% (PBO), while 37% (4mg) & 21% (2mg) had ≥90% coverage (SALT ≤10) vs 2% (PBO). Olumiant (4mg) also improved eyebrow & eyelash coverage

Ref: PRnewswire   |   Image: Eli Lilly   |  Press Release

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