Beyfortus Output Tripled As Sanofi, AstraZeneca Scale Up For RSV Season
French drugmaker Sanofi SA (NASDAQ:SNY) on Monday said it is shipping Beyfortus (nirsevimab) starting in early Q3 to ensure broad availability well ahead of the 2025-2026 respiratory syncytial virus (RSV) season, which typically starts in November and runs through March.
Sanofi, in collaboration with its partner AstraZeneca plc (NASDAQ:AZN), has tripled production capacity and doubled the number of manufacturing sites since the launch of Beyfortus in 2023.
Immunizations begin in early fall. The current supply for the upcoming season matches the total doses distributed last year, and production continues.
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Sanofi said Beyfortus duration of protection was extended for six months in the EU. This year’s EU shipments are marked by an important change to the Beyfortus EU label, extending the duration of protection through six months so Beyfortus can continue to offer season-long protection for all infants, including older babies immunized just before the RSV season begins.
More than six million babies have been immunized worldwide, and millions more will be immunized this season in more than 40 countries to help protect them from the potentially devastating impact of RSV disease.
In another development, Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi on Saturday presented results from the DISCOVER Phase 4, single-arm, open-label trial assessing Dupixent (dupilumab) in adults and adolescents with moderate-to-severe atopic dermatitis with skin of color.
These are the first clinical trial results for Dupixent in a large population of patients with darker skin tones.
The results, along with the Dupixent Phase 3 trials, demonstrated patients taking Dupixent experienced improvements in signs and symptoms of atopic dermatitis from baseline across many skin tones.
The data were shared at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference. In the trial, 120 patients with atopic dermatitis and skin of color were treated with Dupixent every two weeks using a weight-based dosing regimen.
At 24 weeks:
- 76% achieved a ≥75% improvement in overall disease severity (EASI-75), the primary endpoint. Some patients saw improvements as early as two weeks.
- 53% achieved clinically meaningful improvement in itch (≥4-point reduction on the peak-pruritus numerical rating scale [PP-NRS]). Improvements were seen by some patients as early as two weeks.
- Patients experienced a 53% reduction from baseline in post-inflammatory hyperpigmentation, dropping from 5.1 points (moderate/marked) to 2.4 points (mild).
- Based on patient reporting, 18% were very or extremely bothered by dry skin, compared to 78% at baseline.
- The safety results in the DISCOVER trial were generally consistent with the known safety profile of Dupixent in its approved dermatological indications.
Price Action: REGN stock was trading higher by 1.53% to $500.75, and SNY stock was down 0.99% at $49.97.
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