GSK's Fluarix Gets FDA Nod Under Accelerated Approval Process
This article was originally published in The Pink Sheet Daily
Executive Summary
GlaxoSmithKline expects to provide 8 mil. doses of its influenza vaccine for the 2005-2006 season.
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GlaxoSmithKline's influenza vaccine Fluarix cleared FDA Aug. 31 as the first vaccine to receive an accelerated approval. The approval was based on GSK's demonstration "that after vaccination with Fluarix, adults made levels of protective antibodies in the blood that FDA believes are likely to be effective in preventing flu," FDA explained in a press release. To fulfill the approval requirements, GSK will do further clinical studies "to verify the clinical benefit of the vaccine." GSK's May 25 BLA was based on safety and efficacy data from four clinical studies in approximately 1,200 adults. The primary Phase III study, in 1,000 adults, was conducted in conjunction with the National Institutes of Health in December. As part of its safety assessment, FDA also reviewed data from postmarketing reports from other countries where Fluarix is already approved. Fluarix is currently marketed in 79 countries; the flu vaccine has been in use since 1992. Prior to last year's shortage of flu vaccine, Fluarix had not been available in the U.S. FDA approved GSK's flu vaccine in December for use under an IND, and the Centers for Disease Control & Prevention purchased 1.2 mil. doses for the 2004-2005 season. Facilitating the availability of new sources of flu vaccine was part of FDA's strategy to avoid another shortage. One step that the agency took was to expedite the pre-market approval pathway, including allowing an accelerated approval approach to licensure (1 (Also see "FDA Using “Dual-Track” Plan To Strengthen 2005-2006 Flu Vaccine Supply" - Pink Sheet, 10 Feb, 2005.)). GSK has already begun ramping up production of the flu vaccine. The firm aims to provide 8 mil. doses for the 2005-2006 flu season. Chiron recently reduced its projections for Fluvirin supply for 2005-2006 from 25 mil.-30 mil. doses to 18 mil.-26 mil. doses (2 (Also see "Chiron Response To FDA "483" Report For Fluvirin Plant Expected In Early August" - Pink Sheet, 28 Jul, 2005.)). In a same-day announcement, FDA noted that Chiron had made "significant improvement" in addressing good manufacturing practice violations that led to the shut down of its Liverpool, U.K. manufacturing plant (see 3 (Also see "Chiron Anticipates Fluvirin Shipments Will Begin In Late September/Early October" - Pink Sheet, 31 Aug, 2005.) ). - Mary Jo Laffler |