Dupilumab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | IL4 receptor alpha |
| Clinical data | |
| ATC code | none |
| Identifiers | |
| CAS Number | 1190264-60-8 |
| ChemSpider | none |
| Chemical and physical data | |
| Formula | C6512H10066N1730O2052S46 |
| Molar mass | 146.9 kg/mol |
Dupilumab is a monoclonal antibody designed for the treatment of atopic diseases.[1] This drug was developed by Regeneron Pharmaceuticals. The US Food and Drug Administration has designated dupilumab a “breakthrough therapy” which is designed to speed promising new drugs to market.[2]
Mechanism of action
It binds to the alpha subunit of the interleukin-4 receptor (IL-4Rα).[3] Through blockade of IL-4Rα, dupilumab modulates signaling of both the interleukin 4 and interleukin 13 pathway.
Medical uses
The interleukin 4 and 13 pathways have been implicated in the pathophysiology of allergic disease, particularly asthma and atopic dermatitis.[4][5]
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.[3] In an atopic dermatitis study, 85% 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.[6]
In 2016 good results were announced from the SOLO1 and SOLO2 phase III trials (for atopic dermatitis/eczema symptoms)[7] and the US FDA granted it priority review status with a final decision due by March 2017.[8]
References
- ↑ Statement On A Nonproprietary Name Adopted By The USAN Council - Dupilumab, American Medical Association.
- ↑ Walker, Joseph (2016-05-30). "New Eczema Treatments Could Be Available Soon". Wall Street Journal. ISSN 0099-9660. Retrieved 2016-05-31.
- 1 2 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.
- ↑ Regeneron press release March 2, 2013
- ↑ Regeneron press release October 1, 2016 (PDF-File)
- ↑ 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