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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.

“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.

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…