Sanofi SNY and partner Regeneron Pharmaceuticals REGN announced that the FDA has granted a priority review to its atopic dermatitis drug Dupixent’s (dupilumab) supplemental Biologics License Application (sBLA). The sBLA is seeking label expansion of the drug to include adolescent patients who are 12 years to 17 years of age with moderate-to-severe atopic dermatitis (eczema) and whose disease could not be adequately controlled with topical medications or for whom topical treatment was medically inadvisable. A decision from the FDA on approval of the sBLA is expected by Mar 11, 2019.
The sBLA was based on positive data from a phase III study, which evaluated Dupixent monotherapy. Data showed that signs and symptoms of atopic dermatitis and certain quality of life measures in adolescent patients treated with the drug were significantly improved.
We remind investors that the drug is already approved in the United States and Europe for treating adult patients in similar indication.
Please note that the priority review designation from the FDA is generally granted to drugs with potential to provide significant improvements in the safety and effectiveness of the treatment plus prevention or diagnosis of a serious disease.
Dupixent has shown strong growth so far this year. An expanded patient population will certainly boost the prospects of the drug further. Moreover, the company and partner Regeneron are also working to expand Dupixent’s label in other indications. In October, the FDA approved a label expansion of the drug as an add-on maintenance treatment in adults and adolescents (12 years of age or older) with moderate-to-severe asthma.
However, we note that several other pharma companies are also developing their candidates/drugs for the treatment of atopic dermatitis including Pfizer’s PFE JAK1 inhibitor (PF-04965842), Lilly’s LLY Olumiant and AbbVie’s upadacitinib.
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