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Regeneron Says Australian TGA Granted Approval For EYLEA To Bayer Healthcare

Regeneron Pharmaceuticals Inc (REGN) along with Bayer Healthcare announced on Thursday that the Australian Therapeutic Goods Administration or the TGA has granted approval to Bayer Healthcare for EYLEA injection.

The EYLEA injection is for the treatment of patients with neovascular age-related macular degeneration at a recommended dose of 2 milligrams via intravitreal injection per month for three consecutive months, followed by 2 milligrams via intravitreal injection every two months.

EYLEA Injection, known in the scientific literature as VEGF Trap-Eye, is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. EYLEA acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF) and thereby can inhibit the binding and activation of these cognate VEGF receptors.

"The approval of EYLEA represents an important new option for wet AMD patients in Australia," said George D Yancopoulos, M.D., Ph.D., President of Regeneron Research Laboratories. "EYLEA allows for clinical efficacy that is non-inferior to monthly ranibizumab, but with fewer injections and less frequent office visits. We believe that this may help reduce treatment challenges for wet AMD patients and their physicians in Australia."

Bayer Healthcare plans to launch EYLEA in Australia in the second half 2012.

by RTT Staff Writer

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