The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for dupilumab for the treatment of eosinophilic esophagitis (EoE) in patients 12 years of age and older. The target action date for the FDA’s decision on the application is August 3, 2022.

The sBLA is supported by data from a randomized, double-blind, placebo-controlled phase 3 trial (ClinicalTrials.gov Identifier: NCT03633617), which evaluated the efficacy and safety of dupilumab 300mg administered subcutaneously once weekly in patients 12 years of age and older with EoE (Part A and Part B), along with data from an active long-term extension trial (Part C). The coprimary endpoints were the proportion of patients achieving peak esophageal intraepithelial eosinophil count of 6 or less eosinophils per high-power field, and the absolute change in Dysphagia Questionnaire (DSQ) score, at 24 weeks.

In Part A, dupilumab was associated with a 69% reduction in disease symptoms at week 24 compared with 32% for placebo (P =.0002). Patients in the dupilumab arm experienced a 21.92 point improvement in disease symptoms on the DSQ scale vs a 9.60 point improvement for placebo (P =.0004). Moreover, patients in the dupilumab arm had a 60% reduction in their esophageal eosinophilic count to a normal range compared with 5% for the placebo arm (P <.0001).


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In Part B, treatment with dupilumab led to a 64% reduction in disease symptoms at week 24 compared with 41% for placebo (P =.0008). Patients in the dupilumab arm experienced a 23.78 point improvement in disease symptoms on the DSQ scale vs a 13.86 point improvement for placebo (P =.0001). Additionally, 59% of dupilumab-treated patients achieved histological disease remission compared with 6% of the placebo group (P <.0001).

The safety profile of dupilumab for EoE was generally consistent with its known profile for its approved indications. Injection site reactions were the most commonly reported adverse reactions.

The FDA previously granted Breakthrough Therapy designation to dupilumab for this indication.

Dupilumab is currently marketed under the trade name Dupixent for the treatment of atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyps.

References

  1. FDA accepts Dupixent® (dupilumab) for Priority Review in patients aged 12 years and older with eosinophilic esophagitis. News release. Regeneron Pharmaceuticals, Inc. Accessed April 4, 2022. https://www.prnewswire.com/news-releases/fda-accepts-dupixent-dupilumab-for-priority-review-in-patients-aged-12-years-and-older-with-eosinophilic-esophagitis-301516398.html
  2. Late-breaking data at 2022 AAAAI annual meeting show Dupixent® (dupilumab) significantly improved signs and symptoms of eosinophilic esophagitis. News release. Regeneron Pharmaceuticals, Inc. February 26, 2022. Accessed April 4, 2022. https://investor.regeneron.com/news-releases/news-release-details/late-breaking-data-2022-aaaai-annual-meeting-show-dupixentr
  3. Dupixent® (dupilumab) eosinophilic esophagitis trial meets both co-primary endpoints. News release. Regeneron Pharmaceuticals, Inc. May 22, 2020. Accessed April 4, 2022. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-eosinophilic-esophagitis-trial-meets-both-co

This article originally appeared on MPR