Regeneron eye drug tabbed ‘breakthrough therapy’ by FDA

Marking another significant milestone for Regeneron Pharmaceuticals Inc., the U.S. Food and Drug Administration has designated Eylea, an injectable drug for eye diseases developed and marketed by the Greenburgh-based biotech company, a breakthrough therapy to treat diabetic retinopathy in patients with diabetic macular edema.

Regeneron in its announcement of the FDA”™s Monday decision said diabetic retinopathy is a common complication of diabetes, causing damage to the retina, which may lead to poor vision and vision loss. Diabetic macular edema, or DME, is swelling of the macula, the part of the retina responsible for central, fine vision.

Regeneron officials said DME is the most frequent cause of vision loss in patients with diabetes and eventually can lead to blindness. Of an estimated 29.1 million American adults living with diabetes, 7.7 million have diabetic retinopathy, 1.5 million have been diagnosed with DME and approximately another million cases of DME are undiagnosed, according to Regeneron, the state”™s largest biotech employer.

The FDA granted the designation after two phase 3 clinical trials in which Eylea demonstrated a statistically significant improvement in reducing the severity of diabetic retinopathy in patients with DME after two years of treatment.

In the announcement from Regeneron, Dr. George D. Yancopoulos, the company”™s chief scientific officer and president of Regeneron Laboratories, said, “There are no FDA-approved medicines for diabetic retinopathy and we look forward to working closely with the FDA to potentially bring Eylea to these patients as soon as possible.” He said the company plans to submit a supplemental biologics license application ”“ which allows interstate commerce of the FDA-approved drug ”“ for diabetic retinopathy in patients with DME later this year.

Regeneron officials said the FDA created its breakthrough therapy designation to expedite the development and review of drugs for serious or life-threatening conditions.

Eylea is approved in the U.S., European Union and other countries for the treatment of wet age-related macular degeneration, macular edema following central retinal vein occlusion and diabetic macular edema. Injected into the diseased eye, the drug inhibits the growth of new blood vessels and decreases the ability of fluid to pass through blood vessels, blocking the body”™s growth factors that seem to play a critical role in the development of DME.

A publicly traded company on the Nasdaq Global Select Market, Regeneron reported Eylea net sales in the U.S. of $773.8 million in the first half of this year, up from $643.7 million in the first two quarters of 2013, a 20 percent increase. Second-quarter net product sales of Eylea totaled $414.8 million this year, a nearly 26 percent increase from the second quarter of 2013.