The data revealed the most common indications for short-term corticosteroid use to be upper respiratory tract infections, spinal conditions, and allergies.
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Fasenra is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.
Male patients exhibited the highest rates of oral steroid prescriptions.
“Immunomodulatory therapy should be considered early, because NSAIDs or a short course of oral corticosteroids may be sufficient for symptom remission in recent-onset cases, whereas those with long-standing symptoms often require more intensive and prolonged immunotherapeutic interventions,” the authors write.
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.
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…
The FDA has approved Nucala (mepolizumab; GlaxoSmithKline) for injection as add-on maintenance treatment of patients with severe asthma aged ≥12 years.
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.
Ranolazine, an antianginal drug, has been added as a new contraindication. The labeling states that concomitant use has potential for serious and/or life-threatening reactions.
The FDA has approved the New Drug Application (NDA) for Emend (aprepitant; Merck) for oral suspension for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients aged ≥6 months old.