AbbVie Inc. (ABBV) announced a significant expansion for its immunology drug, Skyrizi (risankizumab), following approval from the U.S. Food and Drug Administration (FDA). The drug is now indicated for use in children six years and older diagnosed with moderate-to-severe plaque psoriasis or active psoriatic arthritis.
This regulatory milestone is directly attributed to the robust data generated from the phase 3 OptIMMize psoriasis clinical trial program. The approval broadens Skyrizi’s market reach within the pediatric dermatology and rheumatology segments, offering a new treatment option for a vulnerable patient population.
In conjunction with the expanded indication, the FDA also approved a new 55 mg pre-filled syringe formulation of Skyrizi. This specific dosage is designed for patients weighing less than 40 kg, addressing a critical need for precise and convenient administration in smaller pediatric patients.
The approval underscores AbbVie’s continued investment in its immunology portfolio and its commitment to addressing unmet needs across various age groups. This development is expected to contribute to Skyrizi’s commercial trajectory, reinforcing its position in the competitive immunology landscape.
