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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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.
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.
Fasenra is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.
Under drug interactions, new clinical comments regarding concomitant systemic/inhaled/nasal/ophthalmic corticosteroids have been added.
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.
In general, the best available evidence pointed to self-management advice, exercise therapy and psychosocial interventions as effective strategies for managing musculoskeletal pain in primary care.