CSL Biotherapies submits Biologics License Application to FDA

CSL Biotherapies has submitted a Biologics License Application (BLA) to the United States Food and Drug Administration (FDA).

Pending approval of that application, CSL Biotherapies will introduce its influenza vaccine to the U.S. marketplace. The company's BLA requests that the vaccine be approved to immunize people 18 years of age and older. The approved vaccine will be made available in both a single-dose, thimerosal-free, pre-filled syringe and in multi-dose vials to provide choice and convenience to caregivers who administer it.

"Our parent company, CSL Limited, has supplied safe and effective influenza vaccine for more than 40 years," said Paul Perreault, Executive Vice President of CSL Biotherapies Worldwide Commercial Operations. "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."

Previous international flu vaccine studies sponsored by CSL Limited, and a clinical trial sponsored by the National Institutes of Health (NIH), form the basis for CSL Biotherapies' BLA submission.

For the NIH-sponsored study, sites across the United States enrolled 1,359 volunteers in a pivotal, Phase III, randomized, double-blind, placebo- controlled multi-center study. The study evaluated the safety, tolerability and immunogenicity of thimerosal-free and thimerosal-containing formulations of influenza vaccine in healthy adults aged 18 to 64 years. CSL Biotherapies supplied the inactivated influenza vaccine for the study.

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