Cendakimab PDUFA preview: IL-13 inhibitor for eosinophilic esophagitis

On June 8, 2026, the FDA is expected to decide whether to approve cendakimab (CC-93538), a recombinant humanized monoclonal antibody targeting interleukin-13 (IL-13), for the treatment of eosinophilic esophagitis (EoE) in adults and adolescents aged 12 years and older. The application was submitted by AbbVie (following its acquisition of the asset through the Arena Pharmaceuticals acquisition) with Priority Review, reflecting the high unmet need in a disease that has seen only one biologic approval to date.

This preview is for gastroenterology access teams, EoE treatment center pharmacists, payer medical directors, and market access strategists who need to understand cendakimab's evidence, regulatory timeline, competitive positioning against Dupixent (dupilumab), and access implications ahead of the PDUFA date.

What cendakimab is and how it works

Cendakimab is a recombinant, humanized, high-affinity, neutralizing monoclonal antibody that targets interleukin-13 (IL-13). It inhibits IL-13 binding to both of its receptors — IL-13Rα1 and IL-13Rα2 — thereby blocking the inflammatory pathway central to EoE pathogenesis.

Key parameters:

IL-13 is a key driver of type 2 inflammation in EoE. It contributes to eosinophil recruitment, epithelial barrier dysfunction, and fibrosis (tissue remodeling and scarring) in the esophagus. Unlike dupilumab, which targets the IL-4/IL-13 pathway upstream by blocking the IL-4Rα receptor, cendakimab specifically and selectively neutralizes IL-13 itself, binding both of its receptor subunits.

The regulatory timeline and development history

Cendakimab has a complex corporate lineage:

• Origin: The molecule was originally discovered by Abbott Laboratories (drug code ABT-308). In March 2013, AbbVie (spun off from Abbott) licensed the asset to Receptos (where it received the code RPC4046), retaining an exclusive option to enter a global co-development collaboration.
• Corporate chain: Receptos was acquired by Celgene in 2015 for $7.2 billion (code CC-93538). Celgene was subsequently acquired by Bristol Myers Squibb in 2019, which advanced the molecule through phase 3.
• AbbVie assumes lead: In February 2025, BMS announced it would not commercialize cendakimab. AbbVie exercised its retained option rights and assumed the lead development role, filing the NDA under Priority Review.
• Phase 3 success: The phase 3 registrational trial (NCT04753697) met both co-primary endpoints and was published in NEJM Evidence (2025;4(10):EVIDoa2500095).
• Priority Review: The FDA granted Priority Review, with a PDUFA date of June 8, 2026.

The phase 3 trial: design and results

The phase 3 trial (NCT04753697) was an international, randomized, double-blind, placebo-controlled, 48-week, treat-through study — one of the largest EoE trials ever conducted, enrolling 430 patients.

Trial design

• Population: 430 patients aged 12–75 with EoE. Key inclusion criteria: peak eosinophil count ≥15 eosinophils per high-power field (eos/hpf), 4 or more days of dysphagia in the 2 weeks prior to enrollment, and complete lack of response to PPI treatment for 8+ weeks.
• Arms: Three arms — cendakimab 360 mg weekly for 48 weeks (QW/QW, n=143); cendakimab 360 mg weekly for 24 weeks then every other week for 24 weeks (QW/Q2W, n=143); placebo for 48 weeks (n=144)
• Co-primary endpoints at week 24: (1) Change from baseline in dysphagia days (measured by a validated patient-reported modified Daily Symptom Diary); (2) Histologic response (peak esophageal eosinophil count ≤6 per high-power field)
• Secondary endpoints: Endoscopic features, safety, durability at 48 weeks

Key results (published NEJM)

Co-primary endpoints (week 24):

• Dysphagia days: Cendakimab QW showed significantly greater reduction vs. placebo (least-squares mean change [SE]: −6.1 [0.3] vs. −4.2 [0.4] days; P<0.001)
• Histologic response: 28.6% with cendakimab QW vs. 2.2% with placebo achieved peak eosinophil count ≤6/hpf (P<0.001)

Secondary endpoints:

• Endoscopic severity: Cendakimab improved endoscopic severity from baseline to week 24 vs. placebo (LS mean change [SE]: −5.2 [0.24] vs. −1.2 [0.34] points)
• Durability: Efficacy was maintained at week 48, with both dosing regimens showing sustained improvements
• Fibrosis biomarkers: Cendakimab reversed biomarkers of epithelial-mesenchymal transition (EMT) and fibrotic tissue remodeling, consistent with phase 2 HEROES trial findings

Safety

• Adverse events occurred in 83.8% (QW/QW) and 84.6% (QW/Q2W) of cendakimab patients vs. 73.4% with placebo through week 48
• The adverse-event profile was not dose-limiting
• No new safety signals emerged during the extension period
• Cendakimab was generally well tolerated over 48 weeks

Important context

• Approximately 70% of patients in the study were either refractory or intolerant to topical steroids, suggesting cendakimab's effect extends to a treatment-experienced population
• Dr. Evan Dellon (UNC Chapel Hill), the study's lead investigator, noted: "Given that this is a phase 3 trial that showed cendakimab was both effective and well-tolerated, the data support potential use in clinical practice if the medication is ultimately approved."

EoE: the disease landscape

EoE is a chronic, immune-mediated inflammatory disease of the esophagus characterized by eosinophil infiltration, leading to difficulty swallowing, food impaction, and progressive esophageal fibrosis and strictures.

Key disease facts:

• Prevalence: Approximately 1 in 700 individuals — a five-fold increase since 2009. EoE is no longer classified as a rare disease.
• Pathophysiology: IL-13 is central to disease pathogenesis, driving eosinophil recruitment, epithelial barrier dysfunction, and fibrosis
• Current treatment options: Proton pump inhibitors (PPIs), swallowed topical corticosteroids (budesonide oral suspension, fluticasone), dietary elimination therapy, and dupilumab (Dupixent)
• Unmet need: Many patients are refractory to or intolerant of topical steroids. Long-term steroid use carries its own risks. There is a need for additional biologic options with different mechanisms.

Competitive positioning vs. Dupixent

Dupixent (dupilumab) is currently the only FDA-approved biologic for EoE, approved in May 2022 for patients aged 12 years and older who weigh at least 40 kg. Comparing the two:

Important caveats on cross-trial comparisons:

• Direct cross-trial comparisons are unreliable due to different trial designs, patient populations, and endpoint definitions
• Cendakimab's histologic response rate of 28.6% appears lower than Dupixent's, but the trials used different definitions and the cendakimab trial enrolled a heavily pre-treated population (70% steroid-refractory or intolerant)
• The true competitive positioning will depend on head-to-head data, payer tiering decisions, and patient preference for dosing frequency

Access implications if approved

Prior authorization expectations

If approved, cendakimab will likely face PA requirements similar to Dupixent for EoE:

• Confirmed EoE diagnosis: Endoscopic and histologic confirmation (biopsy showing ≥15 eosinophils per high-power field)
• Prior therapy documentation: Failure of, intolerance to, or contraindication to PPIs and topical corticosteroids
• Specialist prescriber: Gastroenterologist or allergist/immunologist
• Ongoing monitoring: Periodic endoscopic and histologic reassessment

Step therapy considerations

Payers may require:

1. Trial of PPI
2. Trial of swallowed topical corticosteroid (budesonide oral suspension or fluticasone)
3. Some plans may require Dupixent trial before cendakimab, or vice versa, depending on formulary positioning

Pricing and cost considerations

• Dupixent's wholesale acquisition cost for EoE is approximately $3,800–$4,200/month
• Cendakimab pricing has not been announced; AbbVie is expected to price competitively with Dupixent
• Payers may use the availability of two biologics to drive utilization management, including preferential tiering, step therapy, and exclusions

Distribution channel

• Likely specialty pharmacy distribution
• Subcutaneous injection may allow for self-administration (like Dupixent), reducing the need for office-based administration
• Hub services program details will be announced at launch

What to watch

• FDA decision: June 8, 2026 PDUFA date; watch for approval, complete response letter, or extension
• Labeling language: Whether the FDA approves cendakimab broadly for EoE or includes limitations (e.g., specific prior-therapy requirements in the label)
• AbbVie launch readiness: Pricing announcement, patient support program, specialty pharmacy network, and copay assistance
• Payer tiering: Whether major payers position cendakimab as preferred, non-preferred, or step-therapy-required relative to Dupixent
• Head-to-head data: Whether AbbVie or others pursue comparative effectiveness studies
• Expanded indications: Cendakimab was also studied in eosinophilic gastroenteritis; whether AbbVie pursues broader GI eosinophilic disease indications
• Real-world evidence: Post-marketing data on cendakimab effectiveness in steroid-naïve patients (the phase 3 was predominantly steroid-experienced)
• Ongoing EoE pipeline: Other EoE therapies in development (spesolimab, tezepelumab, lirentelimab) could further fragment the market

Sources

• Dellon ES, et al. "Cendakimab in Adults and Adolescents with Eosinophilic Esophagitis." New England Journal of Medicine. Published 2025. doi: 10.1056/NEJMoa. PubMed PMID: 40985784. https://pubmed.ncbi.nlm.nih.gov/40985784
• ClinicalTrials.gov. "A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis." NCT04753697. https://clinicaltrials.gov/ct2/show/NCT04753697
• Dellon ES. "Promising Phase 3 Cendakimab Data for Eosinophilic Esophagitis." HCPLive. 2024. https://www.hcplive.com/view/evan-dellon-md-mph-promising-phase-3-cendakimab-data-eosinophilic-esophagitis
• Healio. "Cendakimab Sustains 'Promising Results' for Safety, Efficacy in EoE at 48 Weeks." October 29, 2024. https://www.healio.com/news/gastroenterology/20241029/cendakimab-sustains-promising-results-for-safety-and-efficacy-in-eoe-at-48-weeks
• EOS Network. "Phase 3 Study of Cendakimab for Eosinophilic Oesophagitis." Updated May 27, 2026. https://www.eosnetwork.org/news/cendakimab-for-eosinophilic-esophagitis-study
• APFED. "Promising Results of Cendakimab to Treat EoE." November 1, 2024. https://apfed.org/blog/promising-results-of-cendakimab-to-treat-eoe
• Dansfera. "Biotech Catalyst Calendar 2026 — Cendakimab PDUFA June 8, 2026." https://dansfera.com
• LARVOL DELTA. "Cendakimab (CC-93538) / AbbVie, BMS." https://delta.larvol.com/Products?ProductId=4e59e819-67ae-416b-84c9-0d299025c75c
• FDA. "Eosinophilic Esophagitis: Developing Drugs for Treatment — Guidance for Industry." https://www.fda.gov/media/120089/download