Zolgensma is an adeno-associated virus vector-based gene therapy.
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The most common presenting complaints included shortness of breath, rhinorrhea, and hoarseness.
The BLA submission is supported by data from the PATHFINDER clinical program.
To what extent are patients with uncontrolled asthma switched to biologics due to poor treatment adherence vs lack of maintenance therapy efficacy?
Research presented at AAAAI assessed the effectiveness of oral azithromycin in reducing recurrent wheeze in young children.
NAVIGATOR trial results presented at CHEST 2021 show the effect of tezepelumab on peak expiratory flow rates in severe asthma.
Investigators assessed the annualized asthma exacerbation rate (AAER) and the annualized rate of asthma exacerbations requiring hospitalization over 52 weeks.
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.
A post hoc analysis of the NAVIGATOR trial assessed the effectiveness of tezepelumab in patients with severe asthma who used additional controllers medications.