FDA accepts Dupixent sBLA for priority review in prurigo

The US Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) to treat adults with prurigo nodularis, a chronic inflammatory skin disease that causes extreme itch and skin lesions. The target action date for the FDA decision is September 30, 2022.

Dupilumab is being jointly developed by French Pharma major Sanofi (Euronext: SAN) and US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) under a global collaboration agreement and has been a significant growth-driver for the companies.

Sanofi’s 2021 sales of the drug were ~$6 billion, a 52.7% increase from 2020. Some analysts forecast a peak in excess of $10 billion, a target which chief executive Paul Hudson has said publicly he expects the product to achieve.