TARRYTOWN, N.Y. May 23, 2011 /PRNewswire/ — Regeneron
Pharmaceuticals, Inc. (Nasdaq:
REGN) today announced that the U.S. Food and Drug
Administration (FDA) has informed the company that it has scheduled
a Dermatologic and Ophthalmic Drugs Advisory Committee Meeting to
be held on June 17, 2011 to discuss the Company’s Biologics License
Application (BLA) for VEGF Trap-Eye for the treatment of the
neovascular form of age-related macular degeneration (wet AMD).
Under Section 505 of the Federal Food, Drug, and Cosmetic
Act, absent special circumstances, all new chemical entities, such
as VEGF Trap-Eye, are referred to an advisory committee for
review.
Regeneron submitted a Biologics License Application for
marketing approval in wet AMD in the U.S. in February 2011 and
received a Priority Review designation. Under priority
review, the target date for an FDA decision on the VEGF Trap-Eye
BLA is August 20, 2011.
Further information on the advisory committee meeting can be
found in the Federal Register at
http://www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm
About VEGF Trap-EyeVascular Endothelial Growth Factor (VEGF)
is a naturally occurring protein in the body. Its normal role
in a healthy organism is to trigger formation of new blood vessels
(angiogenesis) supporting the growth of the body’s tissues and
organs. However, in certain diseases, such as age-related
macular degeneration, it is also associated with the growth of
abnormal new blood vessels in the eye, which exhibit vascular
permeability and lead to edema.
VEGF Trap-Eye is a fully human fusion protein, consisting of
soluble VEGF receptors 1 and 2, that binds all forms of VEGF-A
along with the related Placental Growth Factor (PlGF). VEGF
Trap-Eye is a specific and hi
‘/>”/>
