The approval was based on data from a phase 3 study that evaluated Dupixent added to low potency topical corticosteroids in children aged 6 months to 5 years with uncontrolled moderate to severe atopic dermatitis.
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The sBLA is supported by data from the phase 3 PRIME2 and PRIME trials that assessed dupilumab in patients 18 years of age and older with prurigo nodularis.
The NDA submission is supported by data from the phase 3 MANDALA trial, which included 3132 patients with moderate to severe asthma.
TRAVERSE trial findings on the efficacy, safety, and OCS-sparring effect of dupilumab for severe OCS-dependent asthma were presented at ATS 2022.
Does omalizumab therapy for patients with moderate to severe allergic asthma affect these patients’ use of antitussives?
What is the difference in efficacy between mepolizumab and benralizumab, 2 biologics approved for the treatment of severe eosinophilic asthma?
The sBLA includes data from the phase 3 OSTRO study, which showed that treatment with subcutaneously administered benralizumab led to statistically significant improvements.
Research presented at AAAAI assessed the effectiveness of oral azithromycin in reducing recurrent wheeze in young children.
How does consumption of processed food by children with atopy and asthma affect the gut microbiota and disease severity?
Is COVID-19 a serious concern for people with asthma? Study results presented at AAAAI 2022 show that this answer is not clear cut.