Human clinical trials show exciting promise for a new drug treatment for moderate and severe asthma, with further potential in treating severe eczema.
Dupilumab, developed by Sanofi and Regeneron Pharmaceuticals Inc., reduced asthma attacks by 87
Human clinical trials show exciting promise for a new drug treatment for moderate and severe asthma, with further potential in treating severe eczema.
Dupilumab, developed by Sanofi and Regeneron Pharmaceuticals Inc., reduced asthma attacks by 87 percent in people with a specific type of asthma, when compared with those given a placebo.
Sally E. Wenzel -- a professor in the University of Pittsburgh School of Medicine's division of pulmonary, allergy and critical care medicine -- led and co-authored the study published in the New England Journal of Medicine. As a consultant to Sanofi, she designed the clinical trials to test the drug's effect on asthma and served as principal investigator.
"Our findings suggest that dupilumab holds promise for the treatment of moderate to severe asthma," she said. "It prevents some of the inflammatory pathways [of asthma] from being activated."
The drug must undergo further clinical trials before Sanofi seeks U.S. Food and Drug Administration approval. While the drug could benefit 50 percent of people with asthma, Dr. Wenzel said, its high cost would limit its use to the most severe cases. It likely would benefit about half of those with the most severe forms of asthma.
Dupilumab also has been tested successfully as a treatment for severe eczema, with Sanofi officials noting interest in eventually testing the drug's effectiveness against other severe allergies and atopic skin disorders -- or those involving skin hypersensitivity to allergens -- including eosinophilic esophagitis, food allergies and sinus problems.
"We are eager to continue with human clinical trails, and we are very encouraged with preliminary results," said Gianluca Pirozzi, Sanofi project leader. "The future holds potential in many diseases which we would be interested in expanding into."
The asthma study involved researchers from Pitt, the drug companies, Colorado Allergy and Asthma Centers, California Allergy & Asthma Medical Group Inc., and Peninsula Research Associates. The next phase of human clinical trials will focus on which cases of asthma would benefit most from dupilumab, determine dosage levels and test whether the drug would be safe and effective in the long term.
About 25 million Americans have asthma, with up to 20 percent not having optimal control of the symptoms despite the availability of modern medications, Dr. Wenzel said, saying that gro