BRIEF—Dupixent sBLA accepted for FDA priority review in COPD

The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) in a sixth potential indication.

Developed by French pharma major Sanofi and the USA’s Regeneron, the blockbuster drug is now seeing authorization as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD).

The target action date for the FDA decision is June 27, 2024.

Regulatory submissions are also under review in China and the European Union.

Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE, prurigo nodularis and CSU in different age populations.