US Food and Drug Administration accepts for review AstraZeneca’s … – AstraZeneca

AstraZenecas Supplemental Biologics License Application (sBLA) for the approval of a self- or caregiver-administered option for FluMist Quadrivalent, a needle-free nasal spray, has been accepted for review by the US Food and Drug Administration (FDA). If approved, FluMist will be the first flu vaccine available to be self-administered by eligible patients or administered by caregivers, adding an additional option to be vaccinated against influenza.

The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer or administer FluMist to eligible patients 2-49 years of age when given instructions for use without any additional guidance. FluMist, which is sprayed into the nose, has extensive data demonstrating comparable effectiveness and acceptable safety relative to other flu vaccines.

The Prescription Drug User Fee Act (PDUFA) date, the FDAs date for a regulatory decision, is expected during the first quarter of 2024. If approved at that time, FluMist is anticipated to be available for self-administration in the US for the 2024/2025 flu season.

Ravi Jhaveri, MD, Division Head, Infectious Disease; Virginia H. Rogers Professor in Infectious Diseases, Professor of Pediatrics (Infectious Diseases), Northwestern University School of Medicine, Chicago, USA said: A self-administered option for FluMist Quadrivalent would leverage the unique attributes of the product, providing a convenient new choice for individuals and families who want to protect their loved ones against flu. Vaccination rates for children and adults under 50 years of age declined in the 2022-2023 flu season, highlighting a need for more accessible solutions. The ability for individuals and parents to choose where to administer an injection-free flu vaccine could help increase access and, subsequently, vaccination rates, and greatly benefit those most impacted by this serious and contagious respiratory illness.

Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, said: For more than 20 years, FluMist Quadrivalent has served as a critical public health tool as the only intranasal flu vaccine providing protection to communities around the world. FluMist now has the potential to be the first and only self-administered flu vaccine, which could revolutionise flu vaccination. Our ambition is for FluMist to be ordered directly to peoples homes, providing an innovative, more accessible option for individuals, families and communities.

Influenza (flu) is a contagious respiratory illness caused by the influenza virus, which can cause serious complications to some groups, such as people 65 years and older, young children, and people with certain health conditions.

Notes

Influenza On average, about 8% of the US population gets sick from flu each season, with a range of between 3% and 11%, depending on the season.1 Children 5 to 17 years of age represent 39% of acute respiratory infection medical visits, even though they only make up about 22% of the US population.2 The impact of influenza extends to work and school, as 47% of days of school missed are due to the illness and working caregivers miss 1-2 days of work to care for household members.3

FluMist Quadrivalent Live Attenuated Influenza Vaccine FluMistQuadrivalentis a quadrivalent live attenuated influenza vaccine (LAIV), which is administered as a nasal spray for the prevention of influenza. FluMist Quadrivalent can be used in appropriate children and adults 2 through 49 years of age. FluMist Quadrivalent is an Advisory Committee on Immunization Practices (ACIP) and American Academy of Pediatrics (AAP) recommended flu vaccine option. FluMistQuadrivalent was originally approved in the US in 2003 and since then almost 200 million doses have been distributed around the world.

AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visitastrazeneca.comand follow the Company on social media@AstraZeneca.

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