Dupilumab, marketed as Dupixent, was first approved by the U.S. Food and Drug Administration (FDA) on March 23, 2017 [1]. This initial approval was for the treatment of moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical therapies, or when those therapies are not advisable [1].
When did Dupixent get approved for other conditions?
Following its initial launch, Dupixent received subsequent approvals for other indications. In October 2018, the FDA approved Dupixent for use in adolescents with moderate-to-severe atopic dermatitis [2]. In February 2019, 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 asthma medications [3]. Further approvals expanded its use to eosinophilic esophagitis in patients aged 12 years and older in May 2022 [4], and to chronic rhinosinusitis with nasal polyps (CRSwNP) in adults in August 2019 [5].
What is the patent situation for Dupixent?
The patent landscape for Dupixent is complex, with multiple patents covering its composition of matter, manufacturing, and methods of use [6]. These patents are crucial for maintaining market exclusivity. DrugPatentWatch.com tracks these patents, providing detailed information on their expiry dates and any potential challenges [6]. For instance, some key composition of matter patents for dupilumab are expected to expire in the mid-2030s, but patent expiry can be subject to litigation and other legal challenges [6].
Can generic versions of Dupixent be launched?
The launch of generic versions, or biosimilars for biologic drugs like Dupixent, is contingent upon patent expiry and regulatory approval. Biosimilar applications are reviewed by regulatory bodies to ensure they are highly similar to the reference product, with no clinically meaningful differences in safety, purity, and potency [7]. The exact timeline for biosimilar entry depends on the successful navigation of patent challenges and the FDA's review process [7].
Who manufactures Dupixent?
Dupixent is a product developed and manufactured through a collaboration between Regeneron Pharmaceuticals and Sanofi [1].
What are the key clinical trial results for Dupixent?
Clinical trials have demonstrated Dupixent's efficacy across its approved indications. For moderate-to-severe atopic dermatitis, studies showed significant improvements in skin clearance and itch reduction compared to placebo [1]. In asthma patients, Dupixent reduced exacerbation rates and improved lung function [3]. For eosinophilic esophagitis, trials indicated significant improvements in dysphagia symptom scores [4], and for CRSwNP, it demonstrated reduction in nasal polyp size and improvement in nasal congestion [5].
Sources:
[1] https://www.fda.gov/drugs/drug-approvals-and-databases/drug-approval-package-dupixent-dupilumab-original-approval
[2] https://news.regeneron.com/news-releases/news-release-details/dupixentdupilumab-approved-us-food-and-drug-administration
[3] https://www.fda.gov/drugs/drug-approvals-and-databases/drug-approval-package-dupixent-dupilumab-asthma-supplemental
[4] https://www.fda.gov/drugs/drug-approvals-and-databases/drug-approval-package-dupixent-dupilumab-eosinophilic-esophagitis-supplemental
[5] https://www.fda.gov/drugs/drug-approvals-and-databases/drug-approval-package-dupixent-dupilumab-crswnp-supplemental
[6] https://drugpatentwatch.com/
[7] https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-biosimilar-products