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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.
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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…
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Asthma Meds Linked to Tx Failure in Older Patients

A study in the American Journal of Respiratory and Critical Care Medicine reports that older asthma patients, particularly those treated with inhaled corticosteroids, appear to be at an increased risk for treatment failure compared to those under the age of 30.
Drugs in the Pipeline

Dupilumab Gets Priority Review for Adolescent Atopic Dermatitis

Dupixent is also being assessed in other allergic/inflammatory conditions, including pediatric atopic dermatitis, pediatric asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, grass allergy, and peanut allergy.
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Dupixent Approved for Chronic Rhinosinusitis With Nasal Polyps

The Food and Drug Administration (FDA) has approved Dupixent (dupilumab; Sanofi and Regeneron) as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP). The approval was based on data from two phase 3 randomized, double blind, placebo controlled trials (SINUS-24 and SINUS-52) that evaluated the safety and efficacy…