FDA accepts PaxVax's BLA for cholera vaccine, grants it priority review

Cholera bacteria--Courtesy of CDC

Just a week after announcing a $105 million investment by Cerberus Capital, PaxVax is inching closer to getting its second vaccine--and potentially the first FDA-approved cholera vaccine--to market. The Redwood City, CA-based company announced Wednesday that the FDA accepted for filing and review the Biologics License Application (BLA) for Vaxchora, its cholera candidate.

The news comes two months after PaxVax submitted the BLA and one year after the candidate met its primary endpoints in a 3,000-patient Phase III trial. The FDA also granted Vaxchora priority review, having identified cholera as an eligible neglected tropical disease under its Priority Review Voucher program, PaxVax said in a statement.

"Travelers residing in the U.S. currently have very few options to protect themselves against cholera when going abroad, and we are pleased with the progress we are making in bringing an effective single-dose cholera vaccine to the U.S. market," said Nima Farzan, PaxVax CEO, in the statement.

PaxVax CEO Nima Farzan

If approved, Vaxchora will not only become the first licensed cholera vaccine in the U.S.; it will also become the first single-dose cholera vaccine. Two other vaccines are available for the disease, but neither is FDA-approved. Valneva markets Dukoral, which it acquired from Johnson & Johnson's ($JNJ) Crucell early this year, and Sanofi's ($SNY) Shantha Biotechnics markets the cheaper Shanchol. Both are two-dose vaccines.

While PaxVax has a number of candidates in its pipeline, including those for anthrax and HIV, it currently markets one vaccine, Vivotif, the typhoid vaccine it acquired from Crucell in 2014. At the time, it was licensed for sale in 27 countries, but in April of this year PaxVax announced that it would expand its commercial network to sell the vaccine. It revealed a series of commercial partnerships and distribution agreements that would help it expand its availability in Europe and Australia. And if Vaxchora is approved, the company said, it will be commercialized through this marketing infrastructure.

- here's the release

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