The submission was based on data from the double-blind, placebo-controlled VOYAGE trial.
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Tezepelumab is an investigational first-in-class human monoclonal antibody that works by blocking thymic stromal lymphopoietin.
Findings from a phase 3b trial showed that a majority of patients with severe eosinophilic asthma treated with benralizumab (Fasenra; AstraZeneca), an interleukin-5 antagonist, were able to eliminate or reduce oral corticosteroid (OCS) use. The open-label, single-arm PONENTE trial assessed the efficacy and safety of reducing OCS use after initiating treatment with benralizumab in nearly…
The randomized, double-blind, placebo-controlled VOYAGE trial included 408 children aged 6 to 11 years with uncontrolled persistent asthma.
Ortikos, an anti-inflammatory corticosteroid, is approved as a once-daily treatment for mild to moderate active Crohn disease and for maintenance of clinical remission.
The FDA has approved Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate; AstraZeneca) for the maintenance treatment of chronic obstructive pulmonary disease.
The FDA has approved a prefilled pen formulation of Dupixent (dupilumab; Sanofi and Regeneron), providing another option for administering the treatment.
The New Drug Application (NDA) for voclosporin (Aurinia Pharmaceuticals) has been submitted to the Food and Drug Administration (FDA) for the treatment for lupus nephritis.
The FDA has expanded the approval of Dupixent® (dupilumab; Regeneron and Sanofi) to include patients aged 6 to 11 years with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
The first-in-class tyrosine kinase inhibitor masitinib decreased asthma exacerbations greater than placebo in patients with severe asthma uncontrolled by oral corticosteroids.