Pfizer on Thursday announced that it had withdrawn its application seeking authorization to market Baxalta’s experimental anthrax vaccine in the United States, citing “developing commercial considerations.”
The U.S. Food and Drug Administration had approved the Canadian company to market an early version of the vaccine for civilians, but without specifying a launch date.
The withdrawal means Baxalta, which was acquired by Pfizer for $14 billion earlier this year, will not be able to begin to sell the vaccine in the U.S. until a final decision is made by the FDA, according to Pfizer.
“While we are disappointed that we will not be able to commercially begin marketing the immunotherapy Baxalta’s experimental anthrax vaccine in the U.S., we are very pleased that Baxalta’s accelerated FDA-directed development plan is generating real value for all Baxalta stakeholders,” said Pfizer chairman and chief executive Ian Read in a statement.
Baxalta’s experimental vaccine is now a non-factor for the roughly 22,000 people in the United States at highest risk for exposure to anthrax.