FDA approves CSL Biotherapies' Aflurina
USA-based CSL Biotherapies, part of Australia's CSL group, says that Aflurina, its influenza virus vaccine, has been approved by the US Food and Drug Administration for the active immunization of people aged 18 and over. The product, which protects against infections caused by influenza strains A and B, marks the company's entry into the lucrative US vaccines market.
The FDA granted Aflurina priority status when it was accepted for review earlier this year (Marketletter April 16). The submission dossier included data from a US National Institutes of Health-sponsored Phase III trial in which the product demonstrated safety, tolerability and immunogenicity in patients aged 18 to 65.
CSL said that the product will be made available in both single-dose, thimerosal-free, pre-filled syringes and in multi-dose vials, and added that it intends to deliver all US shipments before the end of the month in time for the start of this year's influenza season.
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