Boston, MA 09/16/2014 (wallstreetpr) – Regeneron Pharmaceuticals Inc (NASDAQ:REGN) announced that the U.S. Food and Drug Administration granted Breakthrough Therapy designation to EYLEA. The drug targets patients with diabetic macular edema (DME) for the treatment of diabetic retinopathy. The Breakthrough Therapy designation was triggered by the positive results obtained from two late-stage trials of the drug. EYLEA promises hope for millions of patients in the U.S. and around the world.
EYLEA underwent two Phase 3 clinical trials that were identified as VIVID-DME and VISTA-DME. The trials returned compelling statistical results in patients with DME following two years of treatment. The results triggered the Breakthrough Therapy designation as the regulator noted significant potential in the drug for the treatment of treatment of diabetic retinopathy.
Benefits of Breakthrough designation
The Breakthrough Therapy designation earns Regeneron Pharmaceuticals Inc (NASDAQ:REGN) special treatment before the regulator in the development of EYLEA for the treatment of the target disease. Such special treatments include an expedited review of EYLEA. The designation will also earn Regeneron (NASDAQ:REGN) a number of fast track features in the development of EYLEA. A drug must demonstrate credible evidence of ability to handle the targeted condition over the existing treatments, or placebo where no other treatment is available, to earn Breakthrough designation.
Regeneron Pharmaceuticals Inc (NASDAQ:REGN) expects to work closely with the regulator to bring EYLEA to patients suffering from diabetic retinopathy. Officials at the company cited that there are currently no FDA-approved treatments for diabetic retinopathy, yet millions of people in the U.S. and elsewhere are faced with the problem.
EYLEA already carries U.S. and EU approvals for the treatment of DME, wet age-related macular degeneration (AMD), and macular edema following central retinal vein occlusion (CRVO). EYLEA’s approval in these categories has also been secured in other countries beyond the U.S. and EU. Regeneron (NASDAQ:REGN) said it had also submitted for approval of EYLEA for treatment of macular edema following branch retinal vein occlusion (BRVO) in the U.S. and EU.
Inspiring performance
Regeneron Pharmaceuticals Inc (NASDAQ:REGN)’s financial performance in the most recent quarter was source of inspiration as the company breached both earnings and revenue expectations. The company reported revenue of $666 million, ahead of the estimate of $647.99 million in 2Q2014.
