Dendreon Corporation has completed the submission of the
post-approval supplement to the PROVENGE (sipuleucel-T) Biologics License
Application for the Morris Plains, New
Jersey manufacturing facility. Dendreon is requesting
licensure for an additional 36 workstations to manufacture PROVENGE. The
standard U.S. Food and Drug Administration (FDA) review for a post-approval
supplement to a Biologics License Application is typically four months.
“The submission requesting licensure for additional
capacity of the New Jersey manufacturing facility is an important milestone as
we work to make PROVENGE more widely available to the many patients who may benefit
from it,” said Mitchell H. Gold, M.D., president and chief executive
officer.
Dendreon’s manufacturing facility in Morris
Plains, New Jersey is currently operating at 25
percent capacity, with 12 workstations available to manufacture PROVENGE. With
the FDA approval of the post-approval supplement to the Biologics License
Application, the facility will have a total of 48 workstations. PROVENGE is the
first in a new therapeutic class known as autologous cellular immunotherapies.
