Drugs in the Pipeline
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.
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…
Drugs in the Pipeline
Consistent reductions in asthma attacks and improvements in lung function across a broad population of uncontrolled asthma patients.
Drugs in the Pipeline
GlaxoSmithKline announced that the primary endpoint for its Phase 3 study of mepolizumab was met for the reduction in the frequency of exacerbations, in patients with severe eosinophilic asthma.
Drugs in the Pipeline
The disease can be life threatening. Phase 3 study results released last March demonstrated Rituxan substantialy improved pemphigus vulgaris remission rates and successful tapering.
Drugs in the Pipeline
Genentech announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Rituxan (rituximab) for the treatment of pemphigus vulgaris.
Drugs in the Pipeline
The designation was based on data from the Phase 2b PATHWAY trial that evaluated 3 doses of tezepelumab as add-on therapy in patients with a history of asthma exacerbations and uncontrolled asthma receiving inhaled corticosteroids/long-acting β-agonist with or without oral corticosteroids and additional asthma controllers vs placebo.
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 primary endpoint was met with 75% of the benralizumab group reducing their OCS doses compared to 25% in the placebo group. Additionally, 52% of the benralizumab group who had optimized baseline OCS doses of ≤12.5mg/d were able to completely stop OCS use.
Drugs in the Pipeline
The submission was based on data from the double-blind, placebo-controlled VOYAGE trial.
