The BLA submission is supported by data from the PATHFINDER clinical program.
Your search for oral corticosteroids returned 11 results
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 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.
Dupixent, an interleukin-4 receptor alpha antagonist, is currently approved for moderate to severe atopic dermatitis in patients ≥12 years old who are not adequately controlled with topical prescription therapies or when they are not advisable.
Results showed that the 4mg dose of baricitinib plus TCS met the primary end point, with 31.5% of patients achieving EASI75 compared with 17.2% of patients in the placebo plus TCS group (P ≤.05).