FDA rejects supplemental Biologics License Application for benralizumab as treatment for chronic rhinosinusitis with nasal polyps

Submission based on Phase III OSTRO study where benralizumab met both co-primary endpoints (nasal polyp burden & patient-reported nasal blockage after 40 weeks vs. placebo). FDA did not consider data sufficient for regulatory approval. Second phase III study (ORCHID) is underway.

SPS commentary:

In UK, benralizumab is currently licensed as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists.

Source:

Biospace Inc.