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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.
Sanofi has officially opened a new 900,000 square-foot campus at Cambridge Crossing, Massachusetts. This facility, housing 2,500 employees, aims to enhance collaboration among R&D, Medical, and Specialty Care divisions, facilitating the development of innovative treatments. The campus features state-of-the-art environmental designs, including CO2 sensors and rainwater harvesting systems for efficiency. The opening aligns with Sanofi's Play to Win strategy to drive growth and innovation, supported by local government leaders highlighting its role in enhancing Massachusetts' health and life sciences ecosystem.
The FDA has accepted Dupixent (dupilumab) for Priority Review to treat prurigo nodularis, a chronic skin disease. If approved, Dupixent will be the first medicine specifically indicated for this condition in the U.S. The target decision date is September 30, 2022. This application is backed by two Phase 3 trials demonstrating significant improvements in symptoms compared to placebo. The most commonly observed adverse event was conjunctivitis. Approximately 75,000 U.S. patients struggle with this disease, highlighting the potential market need for Dupixent.
The FDA has approved Dupixent (dupilumab) 300 mg weekly as the first and only treatment for eosinophilic esophagitis (EoE) in the U.S., benefiting approximately 160,000 patients. In a Phase 3 trial, Dupixent demonstrated a 69% and 64% reduction in symptoms compared to placebo, with a significant histological remission rate of 60% and 59% versus 5% and 6%. This approval marks Dupixent's fourth indication and supports its role in addressing type 2 inflammation-related conditions. Regulatory filings in Europe and other regions are planned in 2022.