Regeneron and Sanofi Receive FDA Approval for Itepekimab in Severe Asthma

Regeneron and Sanofi today announced that the FDA has approved itepekimab as an add-on maintenance treatment for adults with severe uncontrolled asthma not adequately controlled with medium-to-high dose inhaled corticosteroids plus additional controller medicines. In the Phase 3 PATHWAY trial, itepekimab demonstrated a statistically significant reduction in severe asthma exacerbations compared to placebo. Itepekimab is a fully human anti-IL-33 monoclonal antibody that blocks IL-33 signaling, an upstream driver of type 2 inflammation in asthma.