FDA accepts for filing the BLA for Vaxchora (PXVX 0200) vaccine for cholera- PaxVax

PaxVax has announced 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 programme.

Comment: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.

Comment: There are two other cholera vaccines available but neither is FDA approved. Dukoral is marketed by Valneva and Sanofi markets Shanchol via Shantha Biotechnics which are both two dose vaccines in contrast to single dose Vaxchora.