Sanofi/Regeneron’s Dupixent: A First For COPD, But Not The Last

Sanofi and Regeneron Pharmaceuticals, Inc.’s mega-blockbuster Dupixent (dupilumab) has become the first biologic cleared for chronic obstructive pulmonary disease (COPD) in the US. It’s a big indication, but the initial launch trajectory could be slow, and several other biologic drugs are in late-stage development.

The US Food and Drug Administration approved Dupixent, an IL-4/13 inhibitor, for COPD on 27 September, following approvals for the respiratory condition in Europe and China. The US approval, coming after the FDA requested additional efficacy data and delayed action by three months and with labeling in line with the language the European Commission cleared in July, is a relief to investors