French drugmaker Sanofi SA (NASDAQ:SNY) and its partner Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) on Wednesday secured U.S. Food and Drug Administration (FDA) approval for Dupixent (dupilumab) for uncontrolled chronic spontaneous urticaria (CSU) in young children.

Sanofi, Regeneron Win FDA Approval

CSU is a skin condition characterized by itchy hives, swelling (angioedema), or both, appearing almost daily for six weeks or longer without an identifiable trigger.

The approval covers children aged two to 11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 antihistamine (H1AH) treatment, expanding the previous approval for Dupixent in adults and adolescents aged 12 years and older with CSU.

In February, the FDA approved Dupixent for treating allergic fungal rhinosinusitis in patients aged six years and older with a history of sino-nasal surgery.

Dupixent Growth Drives Strong Q1 Sales Beat

Sanofi on Thursday also reported first-quarter sales of $12.31 billion (10.51 billion euros), beating the consensus of $11.99 billion. Sales increased 6.2% year over year, up 13.6% in constant currency.

Dupixent sales increased by 30.8% to 4.17 billion euros. Global sales were driven by strong volume growth across approved indications, and Dupixent retained a leading market position across its disease areas.

Vaccine sales increased by 2.1% to 1.29 billion euros, driven by the newly acquired Heplisav-B and higher sales of Beyfortus.

Beyfortus sales were 284 million euros and increased by 2.8%.

Profitability Improves As Earnings Top Estimates

The French drug maker reported first-quarter business operating income of 2.97 billion euros, up 2.2% year over year and 10.9% in constant currency.

The company reported adjusted EPS of 1.88 euros or $1.10 per ADS, beating the consensus of 1.06 cents, up 5% (+14% on constant currency).

Sanofi Reiterates 2026 Growth Outlook

Olivier Charmeil, interim CEO, said, "We reiterate our guidance for 2026: we continue to expect sales to grow by a high single-digit percentage and business EPS to grow slightly faster than sales, at constant exchange rates, delivering profitable growth. We are looking forward to welcoming Belén Garijo as the new CEO of Sanofi from next month."

SNY Price Action: Sanofi shares were up 3.05% at $48.33 at the time of publication on Thursday, according to Benzinga Pro data.

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