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 New Drug Application (NDA) for voclosporin (Aurinia Pharmaceuticals) has been submitted to the Food and Drug Administration (FDA) for the treatment for lupus nephritis.
Updated on 6/16 While no specific treatment for coronavirus disease 2019 (COVID-19) is currently available, several therapies are being investigated globally.* AB201 (ARCA biopharma): a selective inhibitor of tissue factor being developed as a potential treatment for COVID associated coagulopathy. Clinical testing is expected to begin in the second half of 2020. Acalabrutinib (AstraZeneca): a…
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).
Treatment with masitinib, a selective tyrosine kinase inhibitor, significantly reduces the rate of severe asthma exacerbations in patients with severe asthma uncontrolled by oral corticosteroids, according to data from a phase 3 study.
Adding baricitinib to topical corticosteroids significantly improved disease severity in adult patients with moderate to severe atopic dermatitis, according to top-line results from BREEZE-AD7 study. The phase 3 study included 300 patients who had been diagnosed with moderate to severe atopic dermatitis for at least 12 months and had an inadequate response to topical medications.…
The Food and Drug Administration (FDA) has granted Orphan Drug designation to dexpramipexole (Knopp Biosciences), an investigational treatment for hypereosinophilic syndrome (HES). HES is characterized by peripheral eosinophilia with evidence of organ involvement. Treatment depends on the severity of the condition and underlying cause; while steroid therapy is effective in most patients, high doses are…