The U.S. Food and Drug Administration on Wednesday granted emergency use authorization (EUA) to AstraZeneca Plc’s cervical cancer vaccine candidate AG-CNF12b-01 in the company’s advanced development pipeline and confirmed results in clinical trials.
An earlier version of this article incorrectly identified an FDA decision. See here. The article corrects the name of the study performed in conjunction with AstraZeneca’s UNILROM center in Oxford, not the Lillehammer unit.
This was the latest move by the agency to speed approvals of AG-CNF12b-01, the first HPV vaccine candidate approved for routine use in patients enrolled in traditional clinical trials.
The clearance in the EUA review of AG-CNF12b-01 “is an important milestone and reinforces the ability of our regulatory system to prioritize product candidates for development at the highest public health, societal, and ethical levels”, FDA Commissioner Scott Gottlieb said in its statement.
“We will continue to evaluate every aspect of the vaccine candidate. “We are pleased to report the FDA’s approval of AG-CNF12b-01 in initial EUA purpose study results,” Gottlieb said.
An AstraZeneca’s website claims it now has over 1.4 million sales of its proven HPV vaccine candidate, Aurora Sky. There are currently no approved doses in routine practice.
In June, the agency said it would allow AstraZeneca and Lillehammer to begin clinical studies of its AG-CNF12b-01 vaccine candidate. But it was not immediately clear when this would happen.
AG-CNF12b-01 uses the European Molecular Biology Receptor 2 (EMR) gene to elicit antibodies that block HPV 16-related antibodies, which trigger the client’s immune system to create a tolerance defense strategy against the virus.
The two trials are already in late-stage studies phase 3 for their respective indications.