Tuesday, April 16, 2024

Eosinophilic Esophagitis Treatment Dupixent Granted Expanded Approval by FDA

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The U.S. Food and Drug Administration (FDA) has granted an expanded indication for Dupixent (dupilumab), a medication to treat eosinophilic esophagitis developed by Regeneron Pharmaceuticals and Sanofi. The expanded approval allows the use of Dupixent to treat eosinophilic esophagitis (EoE) in pediatric patients aged 1 to 11 years who weigh at least 33 lbs. This regulatory decision marks a significant milestone as Dupixent becomes the first and only FDA-approved medication for eosinophilic esophagitis specifically in this pediatric patient population. Previously, in May 2022, the FDA approved Dupixent for the treatment of eosinophilic esophagitis in patients aged 12 years and older who weighed at least 88 lbs.

Eosinophilic esophagitis is a chronic and progressive condition that can cause damage to the esophagus, severely impacting a patient’s ability to eat. It is associated with symptoms such as heartburn, vomiting, abdominal discomfort, trouble swallowing, food refusal, and failure to thrive. Young children with EoE are particularly vulnerable to its effects.

Dupixent’s Expanded Approval Offers New Hope for Pediatric Eosinophilic Esophagitis Patients

Regeneron’s co-chair, president, and chief scientific officer, George D. Yancopoulos, MD, PhD, highlighted the significance of this approval for pediatric EoE patients. He noted that until now, there were no approved treatment options specifically for EoE in children, leading many to use unapproved medicines that did not target the root cause of the disease. With this expanded approval, Dupixent offers a potential transformation in the standard of care for these young patients by targeting the underlying type 2 inflammation associated with EoE.

Dupixent is an interleukin-4 receptor alpha antagonist with multiple FDA approvals for various conditions, including EoE in older patients, atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, and prurigo nodularis.

The approval of the expanded indication for Dupixent was based on data from the Phase III EoE KIDS trial, a randomized, double-blind, placebo-controlled study. The trial consisted of two parts that evaluated the safety and efficacy of Dupixent in pediatric patients under 12 years old. Notably, at baseline, 97% of patients had at least one coexisting type 2 inflammatory disease.

Eosinophilic Esophagitis

Positive Outcomes in Pediatric EoE Patients with Dupixent Treatment Continuation

In Part A of the trial, which included a 16-week double-blind period with 61 patients, 66% of patients who received a higher dose of Dupixent based on weight achieved histological disease remission, compared to only 3% of patients in the placebo group. This achievement met the trial’s primary endpoint.

In Part B, which included a 36-week extended active treatment period for 47 children from Part A, those on Dupixent in Part A remained on the medication, while those on placebo in Part A were switched to Dupixent. Among patients who achieved histological remission in both parts A and B, 53% maintained it at week 52. Additionally, 53% of patients who switched from placebo to Dupixent in Part B achieved histological remission at week 52.

The safety profile observed in Part A of the trial was similar to what had been previously observed in patients older than 12 years of age. Common adverse events associated with treatment included injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections.

This expanded approval provides hope for young patients with EoE who face significant unmet medical needs. Despite existing treatment options, approximately 40% of children under the age of 12 in the U.S. with EoE continue to experience symptoms of the disease. Dupixent’s approval underscores the commitment to addressing the unmet needs of young patients and improving their overall well-being by alleviating the symptoms of EoE.

 

Resource: Pharmexec, January 25, 2024

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