CSL Biotherapies Submits BLA for Flu Vaccine

CSL Biotherapies has submitted a biologics license application (BLA) to the FDA for its influenza vaccine. The BLA requests that the vaccine be approved to immunize people 18 and older. The vaccine would be made available as both a single-dose, thimerosal-free, prefilled syringe and in multidose vials.

The company's vaccine is already available elsewhere in the world. "By extending our influenza vaccine franchise into more geographies, including the U.S., our goal is to help address a large and growing critical public health need," Paul Perreault, executive vice president for CSL Biotherapies, said.

International flu vaccine studies sponsored by CSL's parent company and a clinical trial sponsored by the NIH form the basis for the BLA submission.

The NIH-sponsored study enrolled 1,359 patients at sites across the U.S. in a pivotal, Phase III, randomized, double-blind, placebo-controlled trial. The study evaluated the safety, tolerability and immunogenicity of thimerosal-free and thimerosal-containing formulations of influenza vaccine in healthy adults ages 18 to 64.