Advertisement
News
Advertisement

FDA Schedules Advisory Committee Meeting to Discuss BLA for VEGF Trap-Eye for the Treatment of Wet Age-Related Macular Degeneration

Mon, 05/23/2011 - 9:35am
Bio-Medicine.Org

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

'/>"/>

SOURCE

Advertisement

Share this Story

X
You may login with either your assigned username or your e-mail address.
The password field is case sensitive.
Loading