First-in-Class Oral Cholera Vaccine is Granted Priority Review
PaxVax announced that the Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) for Vaxchora—a single-dose oral cholera vaccine. The FDA have set June 15 as the action date for Vaxchora BLA. If approved, it would become the only anti-cholera vaccine in the US.
The BLA submission is based on positive results from a 10 and 90-day cholera challenge trial; and two separate safety and immunogenicity trials in healthy adults. In addition, Vaxchora successfully met primary endpoints in a Phase 3 trial—demonstrating efficacy in an immunogenicity study of adults aged 46–64 years.
Vaxchora is a single-dose oral vaccine containing the cholera strain CVD 103-HgR. This strain has been in-licensed from the University of Maryland School of Medicine's Center for Vaccine Development in 2010.
For more information call (800) 533-5899 or visit Paxvax.com.