Genentech announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Rituxan (rituximab) for the treatment of pemphigus vulgaris.
The FDA has approved Simponi (golimumab for subcutaneous injection; Janssen Biotech) to induce and maintain clinical response in adults with ulcerative colitis.
The FDA has approved a prefilled pen formulation of Dupixent (dupilumab; Sanofi and Regeneron), providing another option for administering the treatment.
A panel of expert advisors to the U.S. Food and Drug Administration voted overwhelmingly against moving the allergy drug Singulair from prescription to over-the-counter status.
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 oralcorticosteroids and additional asthma controllers vs placebo.
Children with protective bedding went much longer before having an exacerbation that led to an emergency room visit or hospital stay for treatment with systemic corticosteroids.
The FDA has approved the use of Dupixent (dupilumab; Sanofi and Regeneron) to treat moderate-to-severe atopic dermatitis in adolescent patients 12–17 years old.
Currently, COPD guidelines recommend that patients with acute exacerbations be treated with systemic corticosteroids for 7-14 days, however, an updated review suggests that corticosteroid treatment of a shorter duration may be as effective as conventional longer-duration therapy.
