CSL submits influenza vaccine BLA to FDA

USA-based CSL Biotherapies, part of Australian group CSL, says that it has submitted a Biologics License Application to the Food and Drug Administration requesting approval to market its influenza vaccine. The filing requests clearance for its use in the immunization of people over the age of 18.

CSL said that, pending regulatory acceptance, it intends to make the product available as both a single dose, thimerosal-free, prefilled syringe, and as a multi-dose vial. The firm added that the BLA includes data from its own clinical trials, as well as from a US National Institutes of Health-sponsored assessment that examined the product's safety, efficacy and tolerability in 1,359 healthy volunteers between the ages of 18 and 64.

In February last year, CSL announced that it was in the process of doubling its production capacity to 40 million vaccine doses per year, half of which will be sold in the USA (Marketletter February13, 2006).