Regeneron nabs FDA 'breakthrough' tag for new Eylea use in diabetics

Plenty of drugmakers are chasing opportunity in diabetes. The fast-growing epidemic means new therapies are sorely needed. But dealing with diabetes directly isn't the only strategy. Regeneron ($REGN) figures it can score by treating some of the disease's long-term complications.

Namely vision loss, one of the scary consequences of long-term blood sugar problems. Regeneron's Eylea drug--a blockbuster treatment for a variety of eye conditions, including diabetic macular edema--just stepped into the FDA's fast lane as a treatment for diabetic retinopathy.

The agency granted Eylea its coveted "breakthrough therapy" designation for that use, which opens it up to a quick appraisal process. The evidence came from two Phase III trials where Eylea patients showed a statistically significant improvement in their condition, measured by a common grading system for diabetic retinopathy, Regeneron said in a statement.

"Millions of people in the U.S. are living with diabetic eye diseases that can cause vision loss and even blindness," Regeneron CSO George Yancopoulos said in a statement. "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."

The company plans to submit its app for the new use later this year, Yancopoulos said.

The market is large: Of the 29 million U.S. adults living with diabetes, 7.7 million have diabetic retinopathy, Regeneron said. About 1.5 million have a DME diagnosis, and another 1 million or so have DME but don't know it.

Regeneron nabbed FDA approval for DME in July, and its partner, Bayer, won the same clearance in Europe last month, so it's early days for Eylea in the diabetes market. It's a few years behind its head-to-head rival Lucentis, sold by Roche ($RHHBY) and Novartis ($NVS), which has boasted the same indication in Europe since 2011 and the U.S. since 2012.

But despite competition from Lucentis, Eylea has trounced all sales estimates since its launch in November 2011, topping analyst expectations almost every quarter. Second-quarter sales grew by 26% year-over-year to $415 million.

- see the release from Regeneron

Special Reports: Top 15 drug launch superstars - Eylea | 15 Highest-Paid Biopharma CEOs of 2013 - Leonard "Len" Schleifer - Regeneron

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