Tremfya Approved for Pediatric Psoriasis and Psoriatic Arthritis
On Sept. 29, 2025, the US Food and Drug Administration (FDA) approved two new indications for Tremfya® (guselkumab – Johnson & Johnson Innovation Medicine) to treat moderate-to-severe plaque psoriasis (PsO) and active psoriatic arthritis (PsA) in pediatric patients aged six years and older, weighing at least 40kg. The approval covers pediatric patients with PsO who are candidates for systemic therapy or phototherapy are. Tremfya, a dual-acting monoclonal antibody that blocks interleukin-23 (IL-23) and binds to CD64, targets key drivers of immune-mediated inflammation. It is already approved for the treatment of moderate to severe PsO, active PsA, ulcerative colitis and Crohn’s disease in adults. The latest approval marks the first time an IL-23 inhibitor is indicated in children, adding care for an estimated 20,000 children diagnosed with PsO each year, as well as approximately 14,000 children affected by PsA. Approval for PsO was based on results from the phase III PROTOSTAR trial, which showed that 56% of patients receiving Tremfya achieved Psoriasis Area Severity Index (PASI) 90 at week 16, compared with 16% on placebo (p<0.01). Additionally, 66% of treated patients reached an Investigator’s Global Assessment (IGA) score of 0/1 versus 16% on placebo (p<0.001), with nearly 40% achieving complete clearance. Approval for active PsA was supported by pharmacokinetic extrapolation from adult studies, confirming efficacy and safety in pediatric patients. The recommended pediatric dose for both conditions is 100mg delivered via a 1mL prefilled syringe, with administration as a subcutaneous (SC) injection at week zero, four and then every eight weeks thereafter. The updated prescribing information can be found here.
New IVIG Option, Qivigy, Approved
The FDA approved Kedrion Biopharma’s Qivigy® [immune globulin intravenous (human)-kthm 10%] for the treatment of primary humoral immunodeficiency (PHI) in adults on Sept. 26, 2025. Qivigy is an intravenous immune globulin (IVIG) therapy designed to restore antibody levels in patients with compromised immune systems, like PHI, who are at risk of repeated, serious infection. Approval was based on pharmacokinetic data and clinical evidence demonstrating effective IgG trough levels and a favorable safety profile. Given intravenously (IV), the recommended dose is 300 to 800 mg/kg every three to four weeks. The most commonly reported adverse events were headache, upper respiratory tract infections, fatigue, nausea and increased blood pressure. There is also a boxed warning for increased risk of blood clots, renal dysfunction and renal failure. It is expected to be available in early 2026. Here is the prescribing information.
More Denosumab Biosimilars Approved
On Sept. 29, 2025, the FDA approved Hikma Pharmaceuticals and Gedeon Richter’s biosimilars Enoby™ (denosumab-qbde 60mg/mL injection) and Xtrenbo™ (denosumab-qbde 120mg/1.7mL) as alternatives to Amgen’s Prolia® (denosumab) and Xgeva® (denosumab), respectively. Enoby is approved for the treatment of osteoporosis for those at high risk for fracture in certain populations like men, post-menopausal women and those taking glucocorticoids or certain drugs for prostate and breast cancer. It is administered by a healthcare provider as a 60mg SC injection once every six months. Xtrenbo is indicated to prevent skeletal-related events for some patients who have multiple myeloma, bone metastases from solid tumors, giant cell tumors of the bone or hypercalcemia of malignancy. After loading doses, it is administered SC at 120mg once every month by a healthcare provider. Jubbonti® (denosumab-bbdz – Sandoz), the first biosimilar to Prolia, and Wyost®(denosumab-bbdz – Sandoz), the first biosimilar to Xgeva, launched on May 31, 2025. Other biosimilars are expected to launch this year. Enoby and Xtrenbo prescribing information can be found here.
Zepzelca and Tecentriq Approved for First-Line Maintenance in ES-SCLC
On Oct. 2, 2025, the FDA approved a new first-line combination for maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), a highly aggressive disease with limited treatment options. Genentech’s Tecentriq® (atezolizumab) was approved in 2019 in combination with chemotherapy for first-line treatment of ES-SCLC and is now approved in combination with Jazz Pharmaceuticals’ Zepzelca® (lurbinectedin) for the first-line maintenance treatment of adult patients with ES-SCLC whose disease has not progressed following induction therapy with Tecentriq, carboplatin and etoposide. Zepzelca is also approved for the second-line treatment of ES-SCLC. This approval also applies to Genentech’s Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs), the SC formulation. Approval was based on the phase III IMforte trial, which demonstrated a statistically significant improvement in progression-free survival (PFS) and overall survival (OS) with the combination versus Tecentriq alone. The US National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN Guidelines®) have been updated to include the regimen as a Category 2A, preferred option for maintenance therapy in patients with ES-SCLC following induction treatment with Tecentriq and carboplatin-etoposide. Here is the updated prescribing information for Zepzelca, Tecentriq and Tecentriq Hybreza.