Regeneron Pharmaceuticals and partner Sanofi announced that the Japanese Ministry of Health, Labour and Welfare granted marketing and manufacturing authorization for Dupixent (dupilumab) to treat severe or refractory bronchial asthma in children aged six to eleven. The approval, issued on December 23 2025, extends Dupixent’s existing pediatric asthma indication, which previously covered patients twelve years and older.
The decision was based on data from the global Phase 3 VOYAGE trial and its open‑label extension, EXCURSION. VOYAGE demonstrated that adding Dupixent to standard of care reduced severe asthma exacerbations by 54% to 65% and improved lung function by 4.68% to 5.32% compared with placebo. The extension data confirmed sustained benefit and safety in the 6‑11‑year age group.
The new indication expands Dupixent’s addressable market in Japan, a country with a large pediatric population and high asthma prevalence. In Q3 2025, Regeneron reported total revenues of $3.75 billion, up 1% year‑over‑year, with collaboration revenue from Sanofi of $1.62 billion driven largely by Dupixent sales. Sanofi’s Q3 2025 results showed total revenue of €12.4 billion, with Dupixent sales reaching €4.2 billion. The approval therefore adds a new revenue stream and strengthens the companies’ positions in the global asthma portfolio.
Management emphasized the strategic importance of the approval. Sanofi CEO Paul Hudson said the company’s “growth momentum” was confirmed by the Q3 results and that the new indication would “further accelerate our trajectory.” Regeneron’s earnings call highlighted that Dupixent and Libtayo were the two products that drove the quarter’s performance, underscoring Dupixent’s role as a key growth engine.
Japan’s pediatric asthma market is sizable, with an estimated 1.5% prevalence among children and a growing demand for biologic therapies. Existing treatment options in the 6‑11‑year age group include inhaled corticosteroids and leukotriene receptor antagonists, but Dupixent’s first‑in‑class mechanism—blocking IL‑4 and IL‑13 signaling—offers a distinct therapeutic advantage. The approval also aligns with Dupixent’s broader strategy of expanding its indications across type 2 inflammatory diseases, where it already has approvals for atopic dermatitis, chronic rhinosinusitis with nasal polyposis, and chronic spontaneous urticaria.
The approval is expected to accelerate Dupixent’s growth in Japan and reinforce its global momentum. With the new pediatric indication, Regeneron and Sanofi anticipate continued revenue expansion, supported by strong demand in other approved indications and a growing biologic market. The companies have signaled confidence in maintaining profitability through disciplined cost management and strategic investments in high‑return segments.
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