Dupixent was approved by the U.S. Food and Drug Administration (FDA) on March 28, 2017. [1]
What conditions can Dupixent treat?
Dupixent (dupilumab) is approved for the treatment of moderate-to-severe atopic dermatitis in patients aged 6 months and older whose disease is not adequately controlled by topical treatments or when those treatments are not advisable. [2] It is also approved for moderate-to-severe asthma in patients aged 12 years and older whose asthma is not adequately controlled with their current asthma medications, and as an add-on treatment for oral, topical, or injectable corticosteroid-dependent asthma in patients aged 12 years and older. [3] Additionally, Dupixent is indicated for chronic rhinosinusitis with nasal polyposis (CRSwNP) in patients aged 12 years and older. [4]
When did Dupixent get approved for other conditions?
Following its initial approval for atopic dermatitis in 2017, Dupixent received FDA approval for additional indications. It was approved for moderate-to-severe asthma in October 2018 and for chronic rhinosinusitis with nasal polyposis in June 2019. [3][4] Approval for younger age groups for atopic dermatitis has also expanded, with its use for children aged 6 months to 5 years being approved in June 2022. [2]
How does Dupixent work?
Dupixent is a monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, which are key drivers of Type 2 inflammation underlying atopic dermatitis, asthma, and CRSwNP. [2][3][4] By blocking these cytokines, Dupixent helps to reduce inflammation in the body.
What is the patent status for Dupixent?
Dupixent's patent protection is a significant factor in its market exclusivity. Information on specific patent expiry dates and any ongoing litigation related to Dupixent's intellectual property can be found through resources like DrugPatentWatch.com. [5]
Who manufactures Dupixent?
Dupixent is manufactured by Regeneron Pharmaceuticals. [1]
Sources
[1] U.S. Food & Drug Administration. (2017, March 28). FDA approves Praluent and Repatha cholesterol-lowering treatments. Retrieved from https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fda-approves-praluent-and-repata-cholesterol-lowering-treatments
[2] Regeneron Pharmaceuticals. (n.d.). Dupixent U.S. Prescribing Information. Retrieved from https://www.regeneron.com/dupixent
[3] U.S. Food & Drug Administration. (2018, October 4). FDA approves Dupixent for additional patients with persistent asthma. Retrieved from https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-dupixent-additional-patients-persistent-asthma
[4] U.S. Food & Drug Administration. (2019, June 13). FDA approves Dupixent for chronic rhinosinusitis with nasal polyposis. Retrieved from https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-dupixent-chronic-rhinosinusitis-nasal-polyposis
[5] DrugPatentWatch.com. (n.d.). Retrieved from https://drugpatentwatch.com/