This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
TheStreet Open House

Regeneron Announces FDA Acceptance Of EYLEAA® (aflibercept) Injection Supplemental Biologics License Application For Review For Diabetic Macular Edema Indication

TARRYTOWN, N.Y., Dec. 18, 2013 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review the Company's supplemental Biologics License Application (sBLA) for EYLEA ® (aflibercept) Injection for the treatment of Diabetic Macular Edema (DME). Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review of an sBLA is ten months from submission, for a target action date of August 18, 2014.

"Diabetes is a growing public health concern and DME is a leading cause of vision loss in patients with diabetic retinopathy," said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories.  "We hope to be able to offer a new treatment option to patients who suffer from diabetic macular edema."

The EYLEA sBLA submission is based on the positive results from the Phase 3 VIVID and VISTA trials.

EYLEA was approved in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD) in November 2011 and for Macular Edema following Central Retinal Vein Occlusion (CRVO) in September 2012.  EYLEA has also been approved in the European Union (EU), Japan, Australia, and in several other countries for use in wet AMD.  EYLEA has also been approved by the European Commission for the treatment of visual impairment due to macular edema following CRVO, as well as in selected countries in Asia and Latin America.  Regulatory submissions have also been made in the EU for EYLEA in DME.

Bayer HealthCare and Regeneron are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States.  Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of EYLEA, except for Japan where Regeneron receives a royalty on net sales.

About the EYLEA ® (aflibercept) Injection Phase 3 DME Program

The Phase 3 DME program consists of three double-masked trials: VIVID-DME, VISTA-DME, and VIVID-EAST-DME (in Russia, China and other Asian countries), and one open-label, single arm safety trial in Japanese patients (VIVID- Japan).  All three double-masked studies have three treatment arms, where patients are randomized to receive either EYLEA 2 mg monthly, EYLEA 2 mg every two months (after 5 initial monthly injections), or the comparator treatment of laser photocoagulation.  The primary endpoint of all three studies is the mean change in best-corrected visual acuity from baseline, as measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart, a standard chart used in research to measure visual acuity.  The VIVID-DME, VISTA-DME, and VIVID-EAST-DME studies are ongoing.

About Diabetic Macular Edema (DME)

DME is a common complication of Diabetic Retinopathy, a disease affecting the blood vessels of the retina.  Clinically significant DME occurs when fluid leaks into the center of the macula, the light-sensitive part of the retina responsible for sharp, direct vision.  Fluid in the macula can cause severe vision loss or blindness.

1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
SYM TRADE IT LAST %CHG

Markets

DOW 17,976.31 +263.65 1.49%
S&P 500 2,086.24 +25.22 1.22%
NASDAQ 4,947.4410 +56.2220 1.15%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs