AstraZeneca : FDA Accepts For Review SBLA For Self-administration Of Flumist Quadrivalent

(RTTNews) - AstraZeneca PLC (AZN.L, AZN) said that its Supplemental Biologics License Application or sBLA for the approval of a self- or caregiver-administered option for Flumist Quadrivalent (Influenza Vaccine Live, Intranasal), a needle-free nasal spray, has been accepted for review by the US Food and Drug Administration.

If approved, Flumist Quadrivalent 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 company noted that the sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer or administer Flumist Quadrivalent to eligible patients 2-49 years of age when given instructions for use without any additional guidance. Flumist Quadrivalent, 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 FDA's date for a regulatory decision, is expected during the first quarter of 2024. If approved at that time, Flumist Quadrivalent is anticipated to be available for self-administration in the US for the 2024/2025 flu season.

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