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Drugs in the Pipeline

Tezepelumab Gets Breakthrough Therapy Designation for Severe Asthma

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.
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FDA Approves Nucala for Severe Asthma

The FDA has approved Nucala (mepolizumab; GlaxoSmithKline) for injection as add-on maintenance treatment of patients with severe asthma aged ≥12 years.
Drugs in the Pipeline

Benralizumab Use Cuts Need for Oral Steroids in Severe Asthma

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.
News

Dupixent sBLA Gets Priority Review for Chronic Rhinosinusitis With Nasal Polyps Indication

Regeneron and Sanofi announced that the Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP). The sBLA included data from two phase 3 randomized, double-blind, placebo-controlled trials (SINUS-24…