Xellia announced that the Food and Drug Administration (FDA) has approved its Premixed Vancomycin Injection in a Ready-to-Use bag.
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The NDA included data from the Phase 3 REVIVE-1 and REVIVE-2 trials.
Nuzyra, an aminomethylcycline (related to tetracycline antibiotics), is designed to overcome tetracycline resistance and has broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria, and other drug-resistant strains.
The approval was based on data from 2 large, multicenter, randomized, double-blind, placebo-controlled Phase 3 trials involving patients with moderate to severe acne vulgaris.
Data from a Phase 2 trial of baricitinib for the treatment of SLE supporting the Fast Track designation were published in The Lancet and presented at the European Congress of Rheumatology earlier this year.
In the ECLIPSE study (N=1048), patients were randomized to receive guselkumab 100mg at weeks 0, 4, and 12 followed by every 8-week dosing or secukinumab 300mg at weeks 0, 1, 2 3, 4 followed by every 4-week dosing.
The approval was supported by data from 2 prospective, multicenter, randomized, double-blind clinical trials.
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.