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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“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.
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.
The data revealed the most common indications for short-term corticosteroid use to be upper respiratory tract infections, spinal conditions, and allergies.
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 designation was supported by data from 7 studies evaluating the safety and efficacy of Xolair against various food allergens (eg, peanut, milk, egg, others).
The randomized, double-blind, placebo-controlled study (N=331) achieved its primary endpoint and key secondary endpoints in the intent-to-treat (ITT) population.
The Sinuva Sinus Implant is a corticosteroid-eluting (mometasone furoate) implant indicated for the treatment of nasal polyps.
Under drug interactions, new clinical comments regarding concomitant systemic/inhaled/nasal/ophthalmic corticosteroids have been added.