FDA Approves Johnson & Johnson's Icotyde for Moderate-to-Severe Plaque Psoriasis

The U.S. Food and Drug Administration has approved Johnson & Johnson's Icotyde (icotrokinra), an interleukin-23 receptor antagonist, for treating moderate-to-severe plaque psoriasis in adults and pediatric patients aged 12 years and older. Icotyde represents a new therapeutic option in the IL-23 inhibitor class, which works by blocking the IL-23 receptor to reduce inflammatory responses associated with psoriasis. The approval expands treatment choices for patients suffering from this chronic autoimmune skin condition that affects millions of Americans. Johnson & Johnson's successful regulatory clearance positions Icotyde to compete in the growing biologics market for psoriasis treatment.

FDA Approval of Icotyde for Plaque Psoriasis

• ▪The U.S. Food and Drug Administration approved Johnson & Johnson's Icotyde (icotrokinra) for the treatment of moderate-to-severe plaque psoriasis
• ▪Johnson & Johnson's Icotyde is approved for adults with moderate-to-severe plaque psoriasis
• ▪Johnson & Johnson's Icotyde is approved for pediatric patients aged 12 years and older with moderate-to-severe plaque psoriasis

Drug Mechanism and Patient Eligibility

• ▪Icotrokinra is the generic name for Johnson & Johnson's Icotyde
• ▪Icotyde (icotrokinra) is an interleukin-23 (IL-23) receptor antagonist

Perspective of Johnson & Johnson

• ▪Johnson & Johnson considers Icotyde's FDA approval a meaningful addition to treatment options for patients with moderate-to-severe plaque psoriasis