AUDENZ

Proper Name: Influenza A (H5N1) Monovalent Vaccine, Adjuvanted

AUDENZ, a sterile injectable emulsion for intramuscular use, is an inactivated, monovalent, subunit influenza vaccine prepared from virus propagated in Madin Darby Canine Kidney (MDCK) cells, a continuous cell line.

Advisory Board:

An Advisory Committee meeting was not held for Audenz since relevant issues regarding licensure of pandemic vaccines were discussed previously at Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings held on February 29, 2012, and November 14, 2012; and because our review of information submitted in the BLA did not raise concerns or controversial issues which would have benefited from an advisory committee discussion.

Indications: AUDENZ is a vaccine indicated for active immunization for the prevention of disease caused by the influenza A virus H5N1 subtype contained in the vaccine. AUDENZ is approved for use in persons 6 months of age and older at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine.

Key Regulatory Milestones:

12/2015 – Fast Track designation was granted

05/07/2014 – Type C meeting between the Center for Biologics Evaluation and Research (CBER) and Novartis Vaccines

06/21/2018 – pre-BLA meeting with Seqirus to discuss the manufacturing, pre-clinical and clinical information Seqirus indicated that the plans had changed since the

02/01/2019 – final submission of the rolling BLA for Audenz, (STN 125692).

01/31/2020 – FDA approval date

02/01/2020 – PDUFA Goal Date

Package Insert