Dupixent single-dose prefilled pens feature a hidden needle and single-press auto-injection.
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NAVIGATOR trial results presented at CHEST 2021 show the effect of tezepelumab on peak expiratory flow rates in severe asthma.
The BLA submission included data from the pivotal phase 3 NAVIGATOR trial that assessed tezepelumab in 1061 patients with severe, uncontrolled asthma.
The approval was based on data from the randomized, double-blind, placebo-controlled phase 3 VOYAGE trial.
Research presented at CHEST 2021 assessed an alternative approach to predicting COPD exacerbations during the COVID-19 pandemic.
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…
The CLEAR study compared clinical outcomes and health resource usage in patients with severe asthma who continued, switched, or stopped their biologic treatment.
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.
Findings may help with decision-making in this high-risk patient population.
The updated labeling is based on results from a safety management cohort from the ZUMA-1 study.