Regeneron Pharmaceuticals Inc. on Wednesday announced the Food and Drug Administration”™s approval of a new use for its drug Eylea as well as positive results from a phase three trial of a cholesterol drug.
The Greenburgh-based pharmaceutical manufacturer announced the FDA approved the use of Eylea for the treatment of diabetic macular edema, a condition in which swelling within the eye can cause vision loss. Eylea is already approved by the FDA for treatment of other forms of macular edema.
Alirocumab, a drug Regeneron is developing with Paris-based pharmaceutical company Sanofi, was shown in nine separate trials to reduce cholesterol levels in patients after 24 weeks. A 10th alternative trial comparing Alirocumab to other drugs also showed positive results.
“The robust data from these studies in more than 5,000 patients is the basis of our global regulatory submissions, which we expect in the U.S. and EU by year end,” said Dr. Elias Zerhouni, Sanofi”™s president of global research and development, in a statement.
Regeneron”™s stock was up more than 8.5 percent in early trading Wednesday, to about $330 per share.
