Regeneron, Sanofi win EU approval for Dupixent in younger children with asthma
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The European Union (EU) has expanded the approval of Dupixent, allowing its use as an add-on maintenance treatment for severe asthma in certain patients aged 6 to 11 years, the developers, Regeneron (NASDAQ:REGN) and Sanofi (NASDAQ:SNY) announced on Thursday.

Accordingly, the interleukin inhibitor is indicated in the region for children whose severe asthma with type 2 inflammation is marked by certain biological indicators and whose disease was not adequately controlled with corticosteroids and another agent as maintenance therapy.
The EU decision was based on data from the pivotal Phase 3 VOYAGE trial, which was designed to evaluate Dupixent with standard of care in 408 children with uncontrolled moderate-to-severe asthma.
Dupixent is a monoclonal antibody designed using Regeneron's (REGN) VelocImmune technology. The U.S. company co-develops it with France-based Sanofi (SNY) under a global collaboration agreement.

The subcutaneous injection generated $6.2 billion net sales in 2021 indicating ~53% YoY growth.