Strengthening Market Dominance Through Expansion of Pediatric Indications

The U.S. Food and Drug Administration (FDA) has approved AbbVie's interleukin-23 (IL-23) inhibitor, Skyrizi (risankizumab-rzaa), for the treatment of plaque psoriasis and psoriatic arthritis in pediatric patients aged 6 years and older. This approval marks a significant milestone, as Skyrizi becomes the first IL-23 inhibitor indicated for pediatric patients, further solidifying its market position. By successfully expanding its indications to include pediatric patients, who were previously limited to adult use, AbbVie is providing new treatment options and addressing an unmet need. This also represents a crucial step for AbbVie in securing a key growth driver to offset the revenue impact of the upcoming patent expiration of its flagship product, Humira.

Efficacy and Safety Demonstrated Through Phase 3 Clinical Data

The approval is based on data from the Phase 3 OptIMMize-1 and OptIMMize-2 studies, which involved pediatric and adolescent patients. In the clinical trials, at week 16, the proportion of patients in the risankizumab arm who achieved PASI 90 was 64.8% in the adolescent cohort, demonstrating superior efficacy compared to ustekinumab (Stelara), which had a PASI 90 rate of 60.7%. Notably, in the cohort of children aged 6 to under 12 years, the PASI 90 achievement rate reached 76.7%, demonstrating a strong therapeutic effect in pediatric patients. Long-term treatment also showed a stable safety profile and sustained response, which is expected to significantly enhance physician confidence in prescribing the drug.

Introduction of a 55mg Formulation for Patients with Low Body Weight

To enable precise dose adjustments based on the body weight of pediatric patients, AbbVie has introduced a new 55mg pre-filled syringe (PFS) formulation. This allows for more precise and safe administration of the drug to pediatric patients weighing less than 40kg, improving ease of administration. Pediatric patients weighing 40kg or more can continue to use the previously approved 150mg dose, enabling personalized treatment based on patient condition. This strategy of improving convenience through formulation diversification will undoubtedly play a decisive role in differentiating Skyrizi from competing products.

Addressing Humira Patent Expiration and Accelerating Revenue Growth

Skyrizi's global revenue in 2024 reached $11.718 billion, and it is projected to surge to $17.562 billion in 2025, demonstrating strong growth. AbbVie aims to leverage this pediatric indication expansion to achieve its long-term financial goal of increasing combined revenue with Rinvoq to over $31 billion by 2027. In particular, amid the biosimilar competition for Humira, a blockbuster drug in the autoimmune disease market, Skyrizi is successfully driving prescription conversions. By capturing a significant share of the global pediatric psoriasis market, which is worth billions of dollars annually, Skyrizi is expected to contribute significantly to long-term revenue defense and the creation of new demand.