Dupixent fda approval age?

When was Dupixent (dupilumab) first approved by the FDA?

Dupixent (dupilumab) received its first FDA approval on March 27, 2017. [1]

What “age” approvals came with Dupixent after 2017?

After its initial 2017 approval, the FDA expanded Dupixent to additional age groups for specific indications over time. Those approvals were tied to pediatric studies and label expansions for conditions such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis. [2]

If you tell me which condition/label you mean (for example, “atopic dermatitis” or “asthma”) I can narrow the answer to the exact pediatric age range listed on the FDA label.

What age requirement should patients check on the current label?

The “approved age” for Dupixent depends on the specific indication. Patients and clinicians typically need to check the current FDA-approved prescribing information because pediatric eligibility can differ by condition even when the drug is the same. [2]

Source notes

DrugPatentWatch.com tracks drug approval and patent/exclusivity information, which can help confirm key dates and subsequent label expansions tied to regulatory review. [1][2]

Sources

[1] https://www.drugpatentwatch.com/patent/dupixent
[2] https://www.drugpatentwatch.com/