Spring 2026 Updates for Biologics in Chronic Rhinosinusitis

Michael J. Marino, MD, and Devyani Lal, MD, on behalf of the Rhinology and Allergy Education Committee

This article highlights key updates from 2025 to early 2026 on biological therapy in chronic rhinosinusitis. Tezepelumab became the fourth FDA-approved add-on maintenance biologic for chronic rhinosinusitis with nasal polyps (CRSwNP), while dupilumab was FDA-approved for allergic fungal rhinosinusitis (AFRS). Both trials extended evidence and labeling into pediatric populations (tezepelumab ≥12 years; dupilumab ≥6 years with weight-based dosing).

Starting in 2019 with dupilumab, biologic therapy has become FDA-approved as an add-on maintenance treatment for patients with CRSwNP. Subsequent FDA approval was granted for omalizumab in 2020 and mepolizumab in 2021 as additional options for add-on biologic therapies in this patient population. These medications are an important treatment option for patients with nasal polyps that are recalcitrant to standard management with topical nasal steroids and endoscopic sinus surgery, and innovation has progressed rapidly in this area. 2025 and early 2026 have seen further advancement with the introduction of another biologic (tezepelumab) for the treatment of CRSwNP and additional indications for CRSwNP subtypes and pediatric patients.

On October 17, 2025, tezepelumab became the fourth biologic to receive FDA approval as an add-on maintenance treatment for CRSwNP. Tezepelumab is a human monoclonal antibody that inhibits receptor binding of thymic stromal lymphopoietin (TSLP) and was previously approved for the treatment of severe asthma. TSLP is an upstream regulator of several inflammatory pathways, including type 2 inflammatory responses implicated in many forms of CRSwNP. In 2023, an exploratory analysis of the NAVIGATOR trial, which enrolled patients with severe asthma, demonstrated an improvement in SNOT-22 scores among patients with nasal polyps treated with tezepelumab compared with placebo.¹ The recent WAYPOINT trial was a randomized, double-blind, placebo-controlled study that specifically enrolled CRSwNP patients, and its results were published in 2025.² Compared to placebo, patients treated with tezepelumab had significant improvements in nasal polyp score (NPS), nasal congestion score (NCS), total SNOT-22 score, and Lund-MacKay score. Systemic corticosteroid use was also significantly less in the group treated with tezepelumab. A subsequent analysis of the WAYPOINT trial also demonstrated improvements in the loss-of-smell score and the University of Pennsylvania Smell Identification Test (UPSIT).³ Finally, an analysis of published clinical trials of biologics used to treat CRSwNP suggested that dupilumab and tezepelumab resulted in similar mean differences in NPS, NCS, and UPSIT.⁴

Allergic fungal rhinosinusitis (AFRS) is a distinct subtype of CRSwNP, although specific guidelines and/or trials for biologic use in this population have been lacking. A 2025 systematic review and meta-analysis demonstrated improvements in SNOT-22 and endoscopic scores in AFRS patients treated with dupilumab, omalizumab, and mepolizumab, including subgroup analyses for each agent.⁵ The studies in that meta-analysis, however, were all retrospective cohorts or case series. The recent LIBERTY-AIMS trial was a randomized, placebo-controlled study that specifically enrolled patients with AFRS to receive dupilumab.⁶ Patients treated with dupilumab in that study showed improvements in NPS, NCS, and Lund-MacKay score. There was also a decreased need for systemic corticosteroids in the dupilumab group. FDA approval for the use of dupilumab in the treatment of AFRS was announced in February 2026, and dupilumab became the first biologic with a specific approval for AFRS.

The WAYPOINT and LIBERTY-AIMS trials allowed for the treatment of pediatric populations. In the WAYPOINT trial, tezepelumab was approved for use in patients with CRSwNP as young as 12 years of age.² Tezepelumab dosing was the same for both adolescents and adults (210 mg every 4 weeks). In the LIBERTY-AIMS trial, children with AFRS as young as six years of age were included for treatment with dupilumab, although weight-based dosing was used for children. Adults and children ≥60 kg were dosed 300 mg every two weeks, while children ≥30 and <60 kg were dosed 200 mg every two weeks. Dupilumab has previously been approved in pediatric populations for other conditions, including infants ≥6 months of age with atopic dermatitis and children ≥6 years of age with asthma, where weight-based dosing regimens were also employed. Before these recent developments, FDA approval of biologic therapies for the treatment of CRSwNP in pediatric patients had been lacking and was acknowledged as an important knowledge gap.⁷

There have been several substantial updates regarding biologic therapies for chronic rhinosinusitis through the early part of 2026. Tezepelumab has gained FDA approval as the fourth biologic agent available for the treatment of nasal polyps following publication of the WAYPOINT randomized controlled trial. Moreover, the LIBERTY-AIMS trial addressed a knowledge gap regarding the efficacy of biologic therapy in AFRS and demonstrated improvements in several outcome measures with dupilumab treatment. Both the WAYPOINT and LIBERTY-AIMS trials were important in extending the indications for treating nasal polyps to pediatric populations. 

Key Takeaways

• Tezepelumab received FDA approval (October 17, 2025) as the fourth add-on maintenance biologic for CRSwNP, expanding options for patients with polyps refractory to standard topical therapy and surgery.
• Dupilumab became the first biologic with a specific FDA indication for AFRS (February 2026), supported by LIBERTY-AIMS, to show improvements in polyp score, congestion, imaging findings, and a decreased need for systemic steroids.
• Both pivotal trials broadened the evidence base for pediatric patients—tezepelumab down to age 12 (fixed 210 mg every four weeks) and dupilumab down to age 6 for AFRS, with weight-based dosing—addressing a prior gap in pediatric CRSwNP biologic use.

References

1. Laidlaw TM, Menzies-Gow A, Caveney S, et al. Tezepelumab Efficacy in Patients with Severe, Uncontrolled Asthma with Comorbid Nasal Polyps in NAVIGATOR. J Asthma Allergy. 2023;16:915–932. doi:10.2147/JAA.S413064
2. Lipworth BJ, Han JK, Desrosiers M, et al. Tezepelumab in Adults with Severe Chronic Rhinosinusitis with Nasal Polyps. N Engl J Med. Mar 27 2025;392(12):1178–1188. doi:10.1056/NEJMoa2414482
3. Mullol J, Han JK, Laidlaw TM, et al. Early and Sustained Improvements in Sense of Smell With Tezepelumab Treatment in Patients With Chronic Rhinosinusitis With Nasal Polyps (WAYPOINT). Int Forum Allergy Rhinol. Jan 6 2026;doi:10.1002/alr.70090
4. Lipworth BJ, Greig R, Chan R, Kuo CR. Reappraisal of Biologic Efficacy from Phase 3 Trials in Refractory Chronic Rhinosinusitis and Nasal Polyps. J Allergy Clin Immunol Pract. Aug 2025;13(8):1943–1951. doi:10.1016/j.jaip.2025.04.043
5. Im YH, Stybayeva G, Hwang SH. Short-Term Efficacy of Biologics in Recalcitrant Allergic Fungal Rhinosinusitis: A Systematic Review and Meta-analysis. Otolaryngol Head Neck Surg. Oct 2025;173(4):840–847. doi:10.1002/ohn.1339
6. Luong A, Levy J, Wise S, et al. Dupilumab Efficacy in Adults and Children Aged 6 and over with Allergic Fungal Rhinosinusitis (Liberty-Aims). Ann Allerg Asthma Im. Nov 2025;135(5)
7. Rahavi-Ezabadi S, Zhou S, Lee SE, et al. Biologic Therapy in Pediatric Chronic Rhinosinusitis: A Systematic Review. Otolaryngol Head Neck Surg. Jul 2024;171(1):35–44. doi:10.1002/ohn.717