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Sanofi (SNY), a global leader in pharmaceuticals and vaccines, provides critical health solutions through its innovative drug development and strategic partnerships. This dedicated news hub offers investors and industry professionals centralized access to official updates and analysis.
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Regeneron Pharmaceuticals and Sanofi announced the publication of significant Phase 3 trial results for Dupixent (dupilumab) in treating children aged 6 months to 5 years with uncontrolled atopic dermatitis. The study demonstrated that Dupixent, in combination with low-potency topical corticosteroids, improved skin clearance, reduced severity of disease, and lessened itch compared to placebo. Safety profiles were consistent with older children. The FDA approved Dupixent for this age group in June 2022, with further regulatory reviews ongoing in Europe.
Regeneron Pharmaceuticals and Sanofi announced positive results from the second Phase 3 trial of Dupixent (dupilumab) for treating prurigo nodularis. At 24 weeks, 60% of patients on Dupixent reported significant itch reduction compared to 18% on placebo. Nearly three times as many Dupixent patients achieved clear skin (48% vs. 18% placebo). Submissions for regulatory approvals are underway in the U.S. and EU. Safety results aligned with established profiles, showing a lower rate of severe adverse events.
Regeneron Pharmaceuticals and Sanofi announced positive results from the longest global Phase 3 trial of Dupixent (dupilumab) in children aged 6 to 11 with uncontrolled moderate-to-severe asthma. The trial showed sustained improvement in lung function and a low rate of severe asthma attacks over two years. Dupixent demonstrated an average of 0.118-0.124 severe asthma attacks per year compared to 2.16-2.56 at baseline. These findings were presented at the 2022 ERS International Congress, coinciding with over 500,000 patients treated with Dupixent worldwide.
The CDC has updated its guidance, recommending Sanofi's Fluzone® High-Dose Quadrivalent and Flublok® Quadrivalent influenza vaccines for adults aged 65 and older. This preferential recommendation aims to reduce flu incidence and complications in this high-risk group. Clinical trials show these vaccines are more effective than standard doses, with Fluzone High-Dose reducing hospitalizations due to flu-related issues by 18% and pneumonia by 28%. Sanofi emphasizes its commitment to improving flu vaccination access for older adults.
Sanofi hosted a panel with public health experts on August 12, 2022, to emphasize the importance of flu vaccinations, especially for high-risk groups like those over 65 and minority communities. The discussion addressed disparities in vaccine uptake among Black Americans and the elderly, both of whom face higher hospitalization risks. Experts predict an uptick in flu cases this season, highlighting the need for effective vaccination strategies. Sanofi aims to combat vaccine fatigue and improve access to flu vaccines through partnerships with healthcare organizations.
Sanofi and the National Institute for Health and Care Research announced the enrollment of the first patient in the Hospitalised RSV Monoclonal Antiody Prevention (HARMONIE) study, targeting the prevention of Respiratory Syncytial Virus (RSV) in infants. This extensive clinical study will evaluate nirsevimab across over 20,000 infants in the UK, France, and Germany, with a focus on reducing RSV hospitalizations. The study commenced with the first patient visit on August 8, 2022, and aims to improve understanding of RSV protection through a single injection.
Sanofi has appointed three new leaders for its U.S. General Medicines and North American Vaccines and Consumer Healthcare divisions. Olivier Bogillot will lead U.S. General Medicines from September 1, moving from his role as President of Sanofi France. Deborah Glasser is the new Head of Vaccines for North America, having previously worked at Biogen. Andrew Loucks will take charge of North America Consumer Healthcare effective August 8, joining from Sensory Cloud. These appointments aim to strengthen leadership and enhance commercial operations.
Sanofi has partnered with Howard University College of Pharmacy to launch a two-year Doctorate in Pharmacy fellowship program aimed at addressing disparities in underrepresented communities. Set to begin in the latter half of 2022, the program will select ten PharmD graduates for practical experiences across diverse fields like oncology and neurology. This initiative marks a significant commitment, being the first industry partnership from Howard University to promise post-fellowship employment. The fellowship aligns with Sanofi's Diversity, Equity & Inclusion strategy, which aims to enhance representation by 2025.
Sanofi has received FDA approval for its Fluzone High-Dose Quadrivalent, Flublok Quadrivalent, and Fluzone Quadrivalent vaccines for the 2022-2023 flu season. This follows a CDC recommendation favoring these vaccines for adults 65 and older, who are at a higher risk of severe flu complications. Notably, Fluzone High-Dose offers superior protection against flu-related hospitalizations and is the only vaccine with a decade of proven efficacy in this demographic. Sanofi aims to enhance vaccination rates among vulnerable populations to mitigate flu-related health risks.
Dupixent has received FDA approval as the first biologic medicine for children aged 6 months to 5 years diagnosed with moderate-to-severe atopic dermatitis. A Phase 3 trial showed that children treated with Dupixent alongside topical corticosteroids achieved 28% clear skin, compared to 4% with corticosteroids alone. The treatment significantly reduced disease severity and itch. Long-term safety data reaffirmed Dupixent's established safety profile. Regeneron and Sanofi aim to address the significant unmet needs of young children suffering from this debilitating condition.
