Navigation Links
Regeneron Provides Update On FDA Advisory Committee Discussion of ARCALYST® (rilonacept) Injection
Date:5/8/2012

TARRYTOWN, N.Y., May 8, 2012 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) voted against approval of ARCALYST® (rilonacept) Injection for Subcutaneous Use for the proposed indication for the prevention of gout flares in patients initiating uric acid-lowering therapy.  The Committee's recommendation will be considered by the FDA in its review of the supplemental Biologics License Application (sBLA) for ARCALYST, but the Committee's recommendation is not binding on the FDA.  Regeneron submitted an sBLA for marketing approval of ARCALYST in the United States and has been granted a target date for an FDA decision of July 30, 2012.

Important information about ARCALYST® (rilonacept) Injection
ARCALYST is currently indicated in the U.S. for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older.  Rilonacept is also approved, but not marketed, in the E.U. for the same patient population.  ARCALYST is not approved, but is currently under review by the U.S. FDA, for the prevention of gout flares in patients initiating uric acid-lowering therapy.

IL-1 blockade may interfere with immune response to infections.  Serious, life-threatening infections have been reported in patients taking rilonacept.  Rilonacept should be discontinued if a patient develops a serious infection.  Taking rilonacept with tumor necrosis factor inhibitors is not recommended because this may increase the risk of serious infections.  Treatment with rilonacept should not be initiated in patients with active or chronic infections.  Patients should not receive a live vaccine while taking rilonacept.  It is recommended that patients receive all recommended vaccinations prior to initiation of treatment with rilonacept.  Patients should be monitored for changes in their lipid profiles and provided with medical treatment if warranted.  Hypersensitivity reactions associated with rilonacept administration have been rare.  Please see the full Prescribing Information for ARCALYST® (rilonacept), available online at www.regeneron.com/ARCALYST-fpi.pdf.

About Regeneron Pharmaceuticals
Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.  Regeneron markets two products in the United States, ARCALYST® (rilonacept) Injection for Subcutaneous Use and EYLEA® (aflibercept) Injection, and has filed regulatory applications with the U.S. Food and Drug Administration (FDA) for second indications for each of these products.  A regulatory application has also been submitted to the FDA for the product candidate ZALTRAP® (aflibercept) Concentrate for Intravenous Infusion.  Phase 3 studies are in progress with EYLEA® in a third indication, and with product candidate sarilumab.  Earlier-stage clinical programs are underway with nine additional monoclonal antibodies.  Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia.  Additional information and recent news releases are available on the Regeneron web site at www.regeneron.com.

Regeneron Forward-Looking Statements
This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron, and actual events or results may differ materially from these forward-looking statements.  These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron's product candidates and research and clinical programs now underway or planned, unforeseen safety issues resulting from the administration of products and product candidates in patients, the likelihood and timing of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates and new indications for marketed products including ARCALYST®, determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's products and drug candidates, competing drugs that may be superior to Regeneron's products and drug candidates, uncertainty of market acceptance of Regeneron's product and drug candidates, unanticipated expenses,  the costs of developing, producing, and selling products, the potential for any license or collaboration agreement, including Regeneron's agreements with the Sanofi Group and Bayer HealthCare, to be canceled or terminated without any product success, and risks associated with third party intellectual property and pending or future litigation relating thereto.  A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2011 and Form 10-Q for the quarter ended March 31, 2012.  Regeneron does not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise, unless required by law.Contacts Information:Manisha Narasimhan, Ph.D.

Peter DworkinInvestor Relations

Corporate Communications914-847-5126

914.847.7640Manisha.narasimhan@regeneron.com 

peter.dworkin@regeneron.com


'/>"/>
SOURCE Regeneron Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Regeneron and Bayer Announce Co-Promotion Agreement With Santen For EYLEA® (aflibercept) Injection in Japan
2. Regeneron to Report First Quarter 2012 Financial and Operating Results and Host Conference Call and Webcast on April 26, 2012
3. Regeneron Announces Data Publication and Presentations with Potential First-in-Class Lipid-Lowering PCSK9 Antibody
4. Regeneron Announces February 2012 Investor Conference Presentations
5. Regeneron to Report Full Year 2011 Financial and Operating Results and Host Conference Call and Webcast on February 16, 2012
6. Regeneron Announces Settlement of Patent Litigation with Genentech for U.S. Ophthalmic Sales of EYLEA™ (aflibercept) Injection
7. Regeneron to Host Conference Call on January 3 at 8:30 a.m. Eastern Time to Discuss Ongoing Patent Litigation
8. Regeneron Announces Presentation Time Change at the 2011 Deutsche Bank BioFEST
9. Regeneron Announces FDA Acceptance of ARCALYST® (rilonacept) Supplemental Biologics License Application for Review
10. Rockefeller University President Marc Tessier-Lavigne Elected to Regeneron Board of Directors
11. Regeneron Announces FDA Approval of EYLEA™ (aflibercept) Injection for the Treatment of Wet Age-Related Macular Degeneration
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... FRANCISCO, Calif. , June 24, 2016 /PRNewswire/ ... ), a biopharmaceutical company developing novel therapeutics for ... unmet needs, today announced the closing of its ... of common stock, at the public offering price ... in the offering were offered by GBT. GBT ...
(Date:6/24/2016)... ALEXANDRIA, Va. , June 24, 2016 ... a set of recommendations that would allow ... information (HCEI) with entities that make formulary and coverage ... determine the "value" of new medicines. The ... that does not appear on the drug label, a ...
(Date:6/24/2016)... , June 24, 2016 According ... by Type (Standard Pen Needles, Safety Pen Needles), Needle ... GLP-1, Growth Hormone), Mode of Purchase (Retail, Non-Retail) - ... This report studies the market for the forecast period ... reach USD 2.81 Billion by 2021 from USD 1.65 ...
Breaking Medicine Technology:
(Date:6/25/2016)... Washington, D.C. (PRWEB) , ... June 25, 2016 ... ... will discuss health policy issues and applications at AcademyHealth’s Annual Research Meeting June ... share their work on several important health care topics including advance care planning, ...
(Date:6/25/2016)... Lewisville, TX (PRWEB) , ... June 25, 2016 , ... ... in the United States, named Dr. Sesan Ogunleye, as the Medical Director of its ... be the facility Medical Director of our new Mesquite location,” said Dr. James M. ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of ... of the latter, setting the bar too high can result in disappointment, perhaps even ... progress toward their goal. , Research from PsychTests.com reveals that behind ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Marcy was in a crisis. Her son James, ... out at his family verbally and physically. , “When something upset him, he couldn’t control ... use it. He would throw rocks at my other children and say he was going ...
(Date:6/24/2016)... ... ... Comfort Keepers® of San Diego, CA is excited to announce they are ... drive cancer patients to and from their cancer treatments. Comfort Keepers provides quality ... and ongoing independence. Getting to and from medical treatments is one of the ...
Breaking Medicine News(10 mins):