Dupilumab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | IL4 receptor alpha |
| Clinical data | |
| Trade names | Dupixent |
| Routes of administration | Injection |
| ATC code |
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| Legal status | |
| Legal status |
|
| Identifiers | |
| CAS Number | |
| ChemSpider |
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| KEGG | |
| Chemical and physical data | |
| Formula | C6512H10066N1730O2052S46 |
| Molar mass | 146.9 kg/mol g·mol−1 |
Dupilumab is a monoclonal antibody designed for the treatment of atopic diseases such as eczema.[1][2] Side effects include allergic reactions, cold sores, and inflammation of the cornea.[2]
It was developed by Regeneron Pharmaceuticals and Sanofi Genzyme.[3][4] The US Food and Drug Administration has designated dupilumab a “breakthrough therapy” which is designed to speed promising new drugs to market.[5] It received FDA approval in 2017.[2] As of 2017 it costs about 37,000 USD per year.[6]
Medical uses
The interleukin 4 and 13 pathways have been implicated in the pathophysiology of allergic disease, particularly asthma and atopic dermatitis.[7][8]
Mechanism of action
It binds to the alpha subunit of the interleukin-4 receptor (IL-4Rα).[9] Through blockade of IL-4Rα, dupilumab modulates signaling of both the interleukin 4 and interleukin 13 pathway.
Clinical trials
In 2013, mid-stage data was presented at the American Thoracic Society meeting and published in the NEJM demonstrating an 87% (placebo: 67%) reduction in asthma exacerbations in patients with moderate-to-severe allergic asthma.[9] In an atopic dermatitis study, 85% (36 percent or 85 out of 671 patients) of patients improved their symptoms by at least 50% within twelve weeks (measured by eczema area and severity index), versus 35% in the placebo group.[10]
In 2016, favorable results were announced from the SOLO1 and SOLO2 phase III trials (for atopic dermatitis/eczema symptoms)[11] and the US FDA granted it priority review status.[12] On March 28, 2017, the U.S. Food and Drug Administration approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema.[13]
References
- ^ Statement On A Nonproprietary Name Adopted By The USAN Council - Dupilumab, American Medical Association.[dead link]
- ^ a b c "FDA approves new eczema drug Dupixent". FDA.
- ^ "Sanofi - Commercial collaboration". Sanofi. Retrieved 2017-03-09.
- ^ "Pipeline | A powerful research and development engine". www.regeneron.com. Retrieved 2017-03-09.
- ^ Walker, Joseph (2016-05-30). "New Eczema Treatments Could Be Available Soon". Wall Street Journal. ISSN 0099-9660. Retrieved 2016-05-31.
- ^ Thomas, Katie (28 March 2017). "Severe Eczema Drug Is Approved by F.D.A.; Price Tag Is $37,000 a Year". The New York Times. Retrieved 30 March 2017.
- ^ Regeneron press release March 2, 2013
- ^ Regeneron press release October 1, 2016 (PDF-File)
- ^ a b Dupilumab in Persistent Asthma with Elevated Eosinophil Levels - Sally Wenzel, M.D., Linda Ford, M.D., David Pearlman, M.D., Sheldon Spector, M.D., Lawrence Sher, M.D., Franck Skobieranda, M.D., Lin Wang, Ph.D., Stephane Kirkesseli, M.D., Ross Rocklin, M.D., Brian Bock, D.O., Jennifer Hamilton, Ph.D., Jeffrey E. Ming, M.D., Ph.D., Allen Radin, M.D., Neil Stahl, Ph.D., George D. Yancopoulos, M.D., Ph.D., Neil Graham, M.D., and Gianluca Pirozzi, M.D., Ph.D., NEJM.
- ^ H. Spreitzer (16 March 2015). "Neue Wirkstoffe – Dupilumab". Österreichische Apothekerzeitung (in German) (6/2015): 16.
- ^ Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. NEJM Oct 2016
- ^ Novel Biologic Dupilumab Improves Eczema Symptoms. Oct 2016
- ^ "FDA approves new eczema drug Dupixent". U.S. Food and Drug Administration. Retrieved March 28, 2017.
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