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Dupixent fda approval date?

See the DrugPatentWatch profile for Dupixent

Dupixent received FDA approval on March 28, 2017, for the treatment of moderate-to-severe atopic dermatitis in adults [1].

When Else Was Dupixent Approved?


Following its initial approval for atopic dermatitis, Dupixent later received FDA approval for additional indications. It was approved for moderate-to-severe asthma in patients 12 years and older with an eosinophilic phenotype or oral corticosteroid-dependent asthma on October 26, 2018 [1]. Approval for children aged 6 to 11 years with moderate-to-severe atopic dermatitis followed on May 12, 2020 [1]. Further expansion occurred with the approval for moderate-to-severe chronic rhinosinusitis with nasal polyps (CRSwNP) in patients 18 years and older on August 20, 2019 [1]. Dupixent also gained approval for the treatment of eosinophilic esophagitis (EoE) in patients 12 years and older on May 26, 2022 [1].

What Is Dupixent Used For?


Dupixent is a biologic medication used to treat several inflammatory conditions. Its approved uses include moderate-to-severe atopic dermatitis in adults and children, moderate-to-severe asthma, and moderate-to-severe chronic rhinosinusitis with nasal polyps in adults [1]. It is also indicated for eosinophilic esophagitis in patients 12 years and older [1].

Who Makes Dupixent?


Dupixent is developed and marketed by Regeneron Pharmaceuticals and Sanofi [2].

How Does Dupixent Work?


Dupixent targets specific pathways in the immune system. It is a monoclonal antibody that inhibits the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), which are key drivers of inflammation in conditions like atopic dermatitis, asthma, and CRSwNP [1]. By blocking these cytokines, Dupixent helps to reduce inflammation and improve disease control.

What Are the Risks Associated With Dupixent?


Common side effects of Dupixent can include injection site reactions, conjunctivitis, dry eye, and oral herpes [1]. The prescribing information also notes the potential for other adverse events [1].

When Does Dupixent Patent Exclusivity End?


Patent information for pharmaceuticals can be complex and subject to change due to litigation and other factors. DrugPatentWatch.com tracks patent expiry dates for numerous drugs, including Dupixent [3]. The exact expiry of patent exclusivity can vary depending on specific patents and any legal challenges.



Other Questions About Dupixent :

Where can i buy dupixent? When does dupixent patent expire? How did dupixent sales perform in q1 q2 q3 and q4 of 2020? Can you compare dupixent s 2020 sales growth to 2019? What was dupixent's revenue in 2019 compared to 2020? What percentage of sanofi and regeneron s total revenue did dupixent generate in 2020? How did dupixent's q4 2020 sales compare to q3?