The Food and Drug Administration will conduct a Priority Review on the supplemental Biologics License Application (sBLA) for dupilumab (Dupixent) as an add-on treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP).
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CRSwNP is a chronic disease of the upper airway in which patients can experience severe nasal obstruction with breathing difficulties, nasal discharge, reduction or loss of sense of smell and taste, and facial pain or pressure. There are currently no FDA-approved treatments for the disease, Regeneron said in the press release.
The sBLA is based on results from a pair of phase 3 trials in which patients with CRSwNP received either dupilumab plus a standard-of-care corticosteroid nasal spray or the standard-of-care spray alone. In results presented at the 2019 annual meeting of the American Academy of Allergy, Asthma, and Immunology, dupilumab plus the spray improved nasal polyp size, nasal congestion severity, chronic sinus disease, sense of smell, and comorbid asthma outcomes while reducing the need for corticosteroid use and nasal/sinus surgery.
Dupilumab is currently approved in the United States to treat moderate to severe atopic dermatitis in adults whose disease is poorly controlled with topical agents and as a maintenance treatment in combination with other asthma medications in patients aged 12 years and older whose disease is not controlled with their current prescription. The most common adverse events include injection-site reactions, oropharyngeal pain, and cold sores.
The target action date for the FDA decision is June 26, 2019, Regeneron said.
Find the full press release on the Regeneron website.