Skyrizi Expands into Pediatric Psoriatic Disease with New Formulation
On June 26, 2026, the US Food and Drug Administration (FDA) approved a new indication and formulation of AbbVie’s Skyrizi® (risankizumab-rzaa). Now approved for the treatment of children six years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, as well as active psoriatic arthritis, this approval includes a new 55mg prefilled syringe to support weight-based dosing in patients weighing less than 40kg. Skyrizi is an interleukin-23 (IL-23) inhibitor previously approved for adults with moderate-to-severe plaque psoriasis, active psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Approval was supported by phase III OptIMMize data demonstrating clinically meaningful psoriasis responses at week 16, with pediatric psoriatic arthritis supported by pharmacokinetic modeling from adult studies. This expanded indication provides a new treatment option for pediatric patients who have psoriasis and psoriatic arthritis, conditions that affect an estimated 20,000 and 14,000 US children, respectively. The recommended dose is 55mg for patients weighing less than 40kg and 150mg for patients weighing 40kg or more, administered subcutaneously (SC) at weeks zero and four, followed by maintenance dosing every 12 weeks. Existing 150mg prefilled syringe and pen formulations remain available for patients weighing 40kg or more. The updated prescribing information may be found here.
Xeomin Label Expanded to Include Pediatric Cerebral Palsy Upper Limb Spasticity
The FDA approved Merz Therapeutics’ Xeomin® (incobotulinumtoxinA) for an expanded indication to include the treatment of upper limb spasticity in children and adolescents aged two years to 17 years of age who have cerebral palsy (CP) on June 26, 2026. First approved in 2010 for adult cervical dystonia, Xeomin’s indications prior to this label update included chronic sialorrhea, upper limb spasticity in adults and pediatric patients aged two years to 17 years (excluding CP), blepharospasm, and select aesthetic indications for facial lines. The label update expands Xeomin’s existing pediatric upper limb spasticity indication to support use in CP, a leading cause of pediatric spasticity, which can impair activities such as dressing, writing, and handling objects, impacting about 213,000 American children. Xeomin is a botulinum neurotoxin type A product administered by intramuscular (IM) injection to reduce muscle overactivity and stiffness. Updated prescribing information may be found here.
Zoryve Cream Expands to Young Children with Plaque Psoriasis
On June 29, 2026, the FDA approved Arcutis Biotherapeutics’ Zoryve® (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis in pediatric patients as young as two years of age, expanding its previous indication in older pediatric patients and adults. Zoryve is a once-daily, steroid-free topical phosphodiesterase-4 (PDE4) inhibitor that can be used anywhere on the body without restrictions on duration of use. Approval in children two years through five years was supported by favorable safety, tolerability, and sustained efficacy consistent with results previously observed in adults and older pediatric patients. Zoryve is the first once-daily non-steroidal therapy approved for plaque psoriasis in children as young as two years of age. The recommended dose is a thin layer applied once daily to affected areas. In addition to this new pediatric plaque psoriasis indication, Zoryve is approved as cream formulations for plaque psoriasis (0.3%) and atopic dermatitis (0.15% and 0.05%) and as a 0.3% foam for seborrheic dermatitis and plaque psoriasis in select pediatric and adult populations. Here is the updated prescribing information.
Casgevy Expands to Young Children for All Indications
The FDA approved Vertex Pharmaceuticals’ Casgevy® (exagamglogene autotemcel) for expanded use on July 1, 2026, for patients two years of age and older with sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs) or transfusion-dependent beta thalassemia (TDT). This extends the autologous gene-edited hematopoietic stem cell therapy beyond its previous approval in patients aged 12 years and older. Casgevy uses clustered regularly interspaced short palindromic repeats (CRISPR) to repair defective genes, increase hemoglobin production, and address the underlying cause of disease through a one-time treatment. Approval was supported by data from two phase III studies in children aged five years to 11 years, in which all 11 treated patients who had SCD were free from VOCs, and eight of nine evaluable patients who had TDT achieved transfusion independence for at least 12 consecutive months. The FDA review also noted that none of the eight evaluable patients who had SCD experienced severe VOCs for at least 12 consecutive months during the first two years after infusion. The expanded indication was further supported through extrapolation of efficacy and safety data to younger pediatric patients. Safety considerations remain consistent with stem-cell transplantation and conditioning regimens, including risks of prolonged cytopenias, infection, bleeding, and transplant-related complications. Administration involves removing stem cells from each patient and altering them to include functional genes that produce normal red blood cells (RBCs). Processing the cells may take up to six months. Patients undergo chemotherapy (chemo) to eliminate the defective blood cell genes and then Casgevy is administered as one IV infusion that contains at least 3 × 106 CD34+ cells/kg. It must be given by trained health care providers in specially equipped medical centers around the United States. Patients must stay in the hospital for several weeks after the infusion to allow immune function to recover. Vertex noted that approximately 5,500 additional children in the US may now be eligible for treatment through more than 75 authorized treatment centers. The application was reviewed under the FDA’s Commissioner’s National Priority Voucher (CNPV) pilot program and approved 53 days after submission, marking the program’s eighth approval. Here is the updated prescribing information.