Drugs in the Pipeline
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…
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Zolgensma is an adeno-associated virus vector-based gene therapy.
Drugs in the Pipeline, News
The FDA's Fast Track process allows for expedited review of drugs that are expected to fill an unmet need.
Drugs in the Pipeline
The BLA submission is supported by data from the PATHFINDER clinical program.
Drugs in the Pipeline
Tezepelumab is an investigational first-in-class human monoclonal antibody that works by blocking thymic stromal lymphopoietin.
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The randomized, double-blind, placebo-controlled VOYAGE trial included 408 children aged 6 to 11 years with uncontrolled persistent asthma.
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The BLA submission included data from the pivotal phase 3 NAVIGATOR trial that assessed tezepelumab in 1061 patients with severe, uncontrolled asthma.
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The approval was based on data from the randomized, double-blind, placebo-controlled phase 3 VOYAGE trial.
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The Food and Drug Administration (FDA) has approved Saphnelo (anifrolumab-fnia) for the treatment of adults with moderate to severe systemic lupus erythematosus who are receiving standard therapy. Type I interferons (IFNs) play a role in the pathogenesis of systemic lupus erythematosus (SLE). Anifrolumab-fnia, a human immunoglobulin G1 kappa monoclonal antibody, binds to subunit 1 of…
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The approval was based on data from three phase 3 trials that evaluated the efficacy and safety of upadacitinib in patients 12 years of age and older with moderate to severe atopic dermatitis who are candidates for systemic therapy.
