FDA Approves Wezlana (ustekinumab-ttwe) for Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, and Ulcerative Colitis

Wezlana is a human interleukin-12 and -23 antagonist.

Wezlana is indicated for the treatment of: - Adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. - Adult patients with active psoriatic arthritis. - Adult patients with moderately to severely active Crohn's disease. - Adult patients with moderately to severely active ulcerative colitis. - Pediatric patients 6 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. - Pediatric patients 6 years and older with active psoriatic arthritis.

**Plaque Psoriasis (Subcutaneous)** - Adults: ≤100 kg: 45 mg at weeks 0 and 4, then every 12 weeks. >100 kg: 90 mg at weeks 0 and 4, then every 12 weeks. - Pediatrics (6 years and older): Weight-based dosing at weeks 0 and 4, then every 12 weeks. <60 kg: 0.75 mg/kg; 60-100 kg: 45 mg; >100 kg: 90 mg.

**Psoriatic Arthritis (Subcutaneous)** - Adults: 45 mg at weeks 0 and 4, then every 12 weeks. For patients with co-existent moderate-to-severe plaque psoriasis weighing >100 kg: 90 mg at weeks 0 and 4, then every 12 weeks. - Pediatrics (6 years and older): Weight-based dosing at weeks 0 and 4, then every 12 weeks. <60 kg: 0.75 mg/kg; ≥60 kg: 45 mg; >100 kg with co-existent moderate-to-severe plaque psoriasis: 90 mg.

**Crohn's Disease and Ulcerative Colitis** - Initial intravenous infusion: weight-based single dose: ≤55 kg: 260 mg; >55 to 85 kg: 390 mg; >85 kg: 520 mg. - Maintenance subcutaneous: 90 mg at week 8 after initial dose, then every 8 weeks.

Trial data not available in label.

Not reported in label.

Wezlana is a biosimilar to Stelara, providing an alternative treatment option for patients with plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Dosing and administration are similar to the reference product.