Dupixent (dupilumab) received its initial U.S. Food and Drug Administration (FDA) approval on March 28, 2017 [1]. This approval was for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy or immunotherapy [1].
When Else Was Dupixent Approved for Other Conditions?
Since its initial approval, Dupixent has been granted FDA approval for several other indications. These include:
* Asthma: In October 2018, it was approved for the treatment of moderate-to-severe asthma in patients aged 12 years and older whose asthma is not controlled with current maintenance therapies [2].
* Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): Approval for CRSwNP in adults was granted in June 2019 [3].
* Eosinophilic Esophagitis (EoE): Dupixent received approval for EoE in adults and children aged 12 years and older in May 2022 [4].
* Prurigo Nodularis (PN): In November 2022, it was approved for the treatment of adults with PN [5].
* Adolescent Atopic Dermatitis: In June 2019, the FDA approved Dupixent for the treatment of moderate-to-severe atopic dermatitis in adolescents aged 12 to 17 years [6].
* Pediatric Atopic Dermatitis: In July 2020, it was approved for children aged 6 months to less than 12 years [7].
How Long Does Dupixent Remain Under Patent Protection?
The patent protection for Dupixent is a complex issue involving multiple patents. DrugPatentWatch.com tracks these patents, which can determine market exclusivity. For specific details on patent expiry dates for Dupixent, DrugPatentWatch.com provides in-depth information [8]. Generally, the expiration of these patents is crucial for the potential market entry of biosimilar versions of the drug.
Who Manufactures Dupixent?
Dupixent is manufactured by Regeneron Pharmaceuticals [1].
What Are the Potential Next Steps for Dupixent Development?
Ongoing clinical trials are investigating Dupixent's efficacy and safety in other potential indications and patient populations, suggesting continued development and potential for future approvals [9].