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 (PsO) who are candidates for phototherapy or systemic therapy, active psoriatic arthritis (PsA), moderately to severely active Crohn's disease (CD), and moderately to severely active ulcerative colitis. It is also indicated for pediatric patients 6 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and active psoriatic arthritis.

For adult plaque psoriasis: patients ≤100 kg receive 45 mg subcutaneously at weeks 0 and 4, then every 12 weeks; >100 kg receive 90 mg at same schedule. For pediatric plaque psoriasis (6 years and older): weight-based dosing: <60 kg: 0.75 mg/kg; 60-100 kg: 45 mg; >100 kg: 90 mg at weeks 0 and 4, then every 12 weeks. For adult psoriatic arthritis: 45 mg subcutaneously at weeks 0 and 4, then every 12 weeks; for patients >100 kg with co-existent moderate-to-severe plaque psoriasis, 90 mg at same schedule. For pediatric psoriatic arthritis (6 years and older): weight-based dosing: <60 kg: 0.75 mg/kg; ≥60 kg: 45 mg; >100 kg with co-existent moderate-to-severe plaque psoriasis: 90 mg at weeks 0 and 4, then every 12 weeks. For Crohn's disease and ulcerative colitis: initial single intravenous infusion based on weight (≤55 kg: 260 mg; >55-85 kg: 390 mg; >85 kg: 520 mg), then subcutaneous 90 mg at week 8 and every 8 weeks thereafter.

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.