Navigation Links
Regeneron Submits Biologics License Application to FDA for VEGF Trap-Eye for Treatment of Wet Age-Related Macular Degeneration
Date:2/22/2011

TARRYTOWN, N.Y., Feb. 22, 2011 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced that the company submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration (wet AMD).  Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review time from submission to FDA action is ten months.  Regeneron's submission includes a request for Priority Review, which, if granted, would shorten the FDA's targeted goal for review time under PDUFA to six months.

"There have been significant advances in the treatment of wet AMD in recent years.  However, the need for monthly intravitreal injections to obtain optimal vision gains has resulted in a significant burden for physicians, patients, and their caregivers," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron.  "We are extremely proud to have conducted the largest global Phase 3 clinical program in patients with wet AMD, which demonstrated that patients treated with VEGF Trap-Eye 2 mg every two months, following three loading doses, were able to be dosed with fewer injections over one year without compromising efficacy.  We look forward to working closely with the FDA to bring this potentially important new medicine to patients with wet AMD."  

The VEGF Trap-Eye BLA is based on the positive results from two Phase 3 trials, the North American VIEW 1 trial and the global VIEW 2 trial.  In these trials, all regimens of VEGF Trap-Eye, including VEGF Trap-Eye dosed 2 milligrams (mg) every two months (following three loading doses), successfully met the primary endpoint of non-inferiority, compared to the current standard of care, ranibizumab 0.5 mg dosed every month.  The primary endpoi
'/>"/>

SOURCE Regeneron Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Bayer and Regeneron Dose First Patient in Second Phase 3 Study for VEGF Trap-Eye in Wet Age-Related Macular Degeneration
2. Bayer and Regeneron Extend Development Program for VEGF Trap-Eye to Include Central Retinal Vein Occlusion
3. Enrollment Completed in Regeneron and Bayer HealthCare Phase 3 Studies of VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration (Wet AMD)
4. Regeneron Announces Presentation at the 18th Annual Credit Suisse Healthcare Conference
5. Regeneron Reports Third Quarter 2009 Financial and Operating Results
6. Sanofi-aventis and Regeneron Expand Strategic Antibody Collaboration
7. Regeneron Announces Presentation at the Deutsche Bank 2009 Biotech Boston Confab
8. BioMed Realty Trust Signs New Lease With Regeneron Pharmaceuticals for 131,000 Square Feet at Landmark
9. Regeneron Announces Presentation at the Morgan Stanley Global Healthcare Conference
10. Regeneron Announces Presentation at the UBS Global Life Sciences Conference
11. Regeneron Announces Panel Discussion at Citis 5th Annual Biotech Day
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/27/2015)... 2015 CryoLife, Inc. (NYSE: CRY ), ... on cardiac and vascular surgery, announced today the appointment ... position of Senior Vice President, Operations, Quality, and Regulatory, ... to Pat Mackin , Chairman, President, and Chief ... is a seasoned industry executive with over 30 years ...
(Date:4/27/2015)... 2015   AMC Health , a leading provider ... monitored care that are transforming chronic care and population ... Conference, May 2-5 at the Los Angeles ... share information about how their innovative programs, solutions and ... personalize healthcare delivery at Booth #2116 and during their ...
(Date:4/27/2015)... , April 27, 2015 PAML announced ... collaborative agreement with Axela, Inc. to develop multiplex ... diseases. PAML is one of the nation,s leading medical ... acid and protein analysis for clinical diagnostics. ... detection strategies, and assay development serves as the ...
Breaking Medicine Technology:CryoLife Appoints William Matthews as Senior Vice President, Operations, Quality, and Regulatory 2AMC Health to Showcase Advances in Monitored Care at ATA 2015 2AMC Health to Showcase Advances in Monitored Care at ATA 2015 3AMC Health to Showcase Advances in Monitored Care at ATA 2015 4PAML and Axela Collaborate on Immune Status for Vaccine Preventable Diseases 2
(Date:4/27/2015)... OH (PRWEB) April 27, 2015 Douglas ... to help his clients feel secure, but also helps secure ... to 7 p.m., Douglas will be manning a booth at ... Center, Lausche Building, 717 E. 17th Ave., Columbus, Ohio. ... worthy event that will feature hundreds of adoptable pets from ...
(Date:4/27/2015)... Ticket Down is a reputable source ... Valley Music Theatre and the Isleta Amphitheater. ... Mexico area can celebrate because their favorite performer will ... Buffett will be performing alongside legendary performers, Huey Lewis ... during the summer and fall months of 2015 are ...
(Date:4/27/2015)... 2015 The global coagulation analyzers ... CAGR in developed countries; however, it is expected ... as China, India and Brazil in the next ... is driven by factors such as increasing adoption ... of high-throughput hemostasis analyzers, developments in high-sensitivity point-of-care ...
(Date:4/27/2015)... 2015 Volpara Solutions today announced ... the Society of Breast Imaging’s SBI/ACR Breast Imaging ... Booth #214). VolparaDensity, the first breast density ... breast tomosynthesis datasets from multiple manufacturers, is already ... and worldwide. , The latest version ...
(Date:4/27/2015)... Puroast Coffee has signed on to sponsor the ... BattleFrog OCR is a series of rigorous courses designed by ... the training that Seals undergo, as well as provide a ... to sponsor the BattleFrog events this year,” says Puroast CEO ... well-suited to give people throughout the country the chance to ...
Breaking Medicine News(10 mins):Health News:Farmers Insurance Agent Douglas Fitzpatrick Ensures Pets Find Homes 2Health News:Cheap Jimmy Buffett Tickets at Alpine Valley Music Theatre in Elkhorn, WI and at Isleta Amphitheater in Albuquerque, NM Now on Sale at TicketDown.com 2Health News:Coagulation Analyzers Market Concluded to Reach $3.58 billion by 2019 2Health News:Coagulation Analyzers Market Concluded to Reach $3.58 billion by 2019 3Health News:Volpara Solutions Releases VolparaDensity 3.1 for Use with Tomosynthesis Systems from Multiple Manufacturers at SBI 2Health News:Volpara Solutions Releases VolparaDensity 3.1 for Use with Tomosynthesis Systems from Multiple Manufacturers at SBI 3Health News:Puroast Coffee on Tour with BattleFrog 2
... Reporter , MONDAY, April 18 (HealthDay News) -- New ... stay clear of AIDS longer if they start drug ... However, starting treatment earlier, compared to waiting, didn,t ... benefit in terms of preventing death" by prescribing the ...
... , MONDAY, April 18 (HealthDay News) -- Patients with ... die after surgery, even after non-emergency procedures, a new study ... be used to revive someone who is clinically unresponsive and ... 18 and in the August print issue of the journal ...
... New research finds that older diabetics with better control of ... as heart attacks, amputation and kidney disease. However, ... sugar levels face a slightly higher chance of dying than ... normal range. Researchers tracked more than 70,000 people with ...
... , MONDAY, April 18 (HealthDay News) -- Infection with ... many college students -- and little exposure to sunlight may ... a new study suggests. "MS is more common at ... researcher, Dr. George C. Ebers, of the University of Oxford ...
... ovarian cancer (HGSOC), the fifth-deadliest cancer among American women, ... fallopian tube malignancy masquerading as an ovarian one. While ... tubes has so far been only circumstantial, a new ... connection, a finding that could aid in the development ...
... Ill. Nearly 800 dental sleep medicine professionals from ... Meeting of the American Academy of Dental Sleep Medicine ... at the Hilton Minneapolis in Minneapolis, Minn. The meeting ... 25th Anniversary Meeting of the Associated Professional Sleep Societies. ...
Cached Medicine News:Health News:Starting HIV Drugs Earlier May Delay AIDS But Not Death 2Health News:Starting HIV Drugs Earlier May Delay AIDS But Not Death 3Health News:People With DNR Orders More Apt to Die After Any Surgery 2Health News:Low Glucose Levels May Raise Death Risk Among Older People 2Health News:Can Common Virus, Lack of Sunlight Boost MS Risk? 2Health News:New scientific model tracks form of ovarian cancer to origins in fallopian tube 2Health News:New scientific model tracks form of ovarian cancer to origins in fallopian tube 3
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
Medicine Products: