Navigation Links
Regeneron Announces FDA Acceptance of ARCALYST® (rilonacept) Supplemental Biologics License Application for Review
Date:11/22/2011

TARRYTOWN, N.Y., Nov. 22, 2011 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's supplemental Biologics License Application (sBLA) for ARCALYST Injection for Subcutaneous Use for the prevention of gout flares in patients initiating uric acid-lowering therapy.  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 July 30, 2012.

"Based on the positive data from our Phase 3 efficacy studies and the more than 1300 patients in our safety study, we believe that ARCALYST has the potential to become an important new therapy for patients with gout who are initiating uric acid-lowering therapies," stated George D Yancopoulos, M.D., Ph.D., President of Regeneron Research Laboratories.  "Gout is a serious and sometimes debilitating disease, characterized by elevated levels of uric acid in the blood, which requires treatment with uric acid-lowering therapy to avoid gout flares and its long-term complications.  Unfortunately, its management is often impeded by painful gout flares that occur early during treatment with standard-of-care uric acid-lowering therapies.  The availability of a treatment that can help avoid gout flares during the initial months of uric acid-lowering therapy has the potential to help patients with this disease."

The sBLA submission for ARCALYST is based on positive efficacy data from PRE-SURGE 1, a North American Phase 3 trial, and PRE-SURGE 2, a similarly designed global Phase 3 trial.  Both trials met the primary endpoint of reduction in the mean number of gout flares per patient during the 16-week treatment period in patients initiating uric acid-lowering therapy.  ARCALYST was generally well tolerated with
'/>"/>

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

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. Rockefeller University President Marc Tessier-Lavigne Elected to Regeneron Board of Directors
2. Regeneron Announces FDA Approval of EYLEA™ (aflibercept) Injection for the Treatment of Wet Age-Related Macular Degeneration
3. Sanofi and Regeneron Report Positive Preliminary Phase 2 Program Results for Anti-PCSK9 Antibody in Hypercholesterolemia
4. Regeneron Pharmaceuticals Announces Pricing of Offering of Convertible Senior Notes due October 1, 2016
5. Regeneron Ranked by Science Magazine as the #2 Employer in the Global Biopharmaceutical Industry
6. Regeneron Announces Clinical Presentations at ASRS 2011 Annual Meeting
7. Regeneron Reports Second Quarter 2011 Financial and Operating Results
8. Sanofi and Regeneron Report Positive Phase 2b Trial Results with Sarilumab in Rheumatoid Arthritis
9. Trading in Regeneron Common Stock Halted
10. Regeneron Reports First Quarter 2011 Financial and Operating Results
11. Regeneron Announces Presentation at the Bank of America Merrill Lynch 2011 Health Care Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/4/2015)... 4, 2015   Mayo Clinic and ... the next generation of wearable biosensors designed to fight ... this technology will be game-changer. These patch biosensors may ... James Levine, M.D., Ph.D. , a Mayo Clinic ... and can be integrated into the care people receive." ...
(Date:3/4/2015)... , March 4, 2015  Results of the ... Consecutive Cases Using MarginProbe for Intra-Operative Positive Margin Detection ... session at the 32 nd Annual Miami Breast ... conducted by Moshe Papa , MD, FACS, Professor ... Tel Aviv University, reports an analysis of MarginProbe,s efficiency ...
(Date:3/4/2015)... 4, 2015  Bayer HealthCare today announced that ... accepted the company,s Biologics License Application (BLA) for ... is seeking FDA approval of the investigational compound, ... hemophilia A in children and adults. ... therapies to hemophilia A patients who need them," ...
Breaking Medicine Technology:Mayo Clinic and Gentag, Inc. Announce Agreement To Develop Wireless Sensors for Treatment of Obesity and Diabetes 2Mayo Clinic and Gentag, Inc. Announce Agreement To Develop Wireless Sensors for Treatment of Obesity and Diabetes 3New Study Shows Breast Re-excision Rates Significantly Reduced in 100 Consecutive Cases 2FDA Accepts Bayer's Biologics License Application for Investigational Treatment Option in Hemophilia A 2FDA Accepts Bayer's Biologics License Application for Investigational Treatment Option in Hemophilia A 3
... Laboratories, L.C. and Intercell AG (VSE; "ICLL") ... of Romark,s antiviral drug, nitazoxanide, in combination ... (HCV) vaccine, IC41, during the first half ... (Logo: http://www.newscom.com/cgi-bin/prnh/20100201/FL47022LOGO) Intercell,s vaccine ...
... Oct. 21 IDEV Technologies, Incorporated (IDEV), an innovative ... medical technologies, today announced another step in the implementation ... treating patients with peripheral vascular disease with the addition ... The initial uses of the newly introduced 180mm and ...
Cached Medicine Technology:Romark and Intercell Join Forces in Combining Therapies Against Hepatitis C 2Romark and Intercell Join Forces in Combining Therapies Against Hepatitis C 3Romark and Intercell Join Forces in Combining Therapies Against Hepatitis C 4Romark and Intercell Join Forces in Combining Therapies Against Hepatitis C 5IDEV Technologies Launches Additional Products in Europe 2
(Date:3/4/2015)... 04, 2015 FDA’s New Inspection Approach:, ... Webinar**, March 24, 2015 — 1:30 p.m. – 3:00 ... know within four hours of an inspection whether a ... on their “good” list, they’ll merely ask for reassurance ... is on the “bad” list, the manufacturer must get ...
(Date:3/4/2015)... the growing influence of movies, television, video games and the ... combined with the increasingly frantic lifestyle of modern parents, it ... with what kids are into these days. It seems that ... basis. , The same is also true for drugs and ... discreetly talk about them, are constantly changing. These tips put ...
(Date:3/4/2015)... (PRWEB) March 04, 2015 Vancouver ... recently received two awards in the prestigious Vancouver ... on February 27, 2015. The company secured third ... place in the “Best Registered Massage Therapist” category. ... community newspapers in Canada, The Vancouver Courier is ...
(Date:3/4/2015)... 2015 State officials have awarded $82,500 ... of Public Health at Georgia State University, to support ... by Georgia’s Division of Family and Children Services (DFCS) ... Call Center. , The 1-800-CHILDREN Helpline is a ... and referral services that promote the wellbeing of children ...
(Date:3/4/2015)... (PRWEB) March 04, 2015 The popular ... of their new L-Style Revolution™ Program. The customized program ... and women of all health and fitness levels to ... goals faster than traditional methods. , “We’re really proud ... customized plans based on award winning techniques to help ...
Breaking Medicine News(10 mins):Health News:FDAnews Announces: FDA’s New Inspection Approach: What Your Inspector Knows in Four Hours Webinar, March 24, 2015 2Health News:FDAnews Announces: FDA’s New Inspection Approach: What Your Inspector Knows in Four Hours Webinar, March 24, 2015 3Health News:FDAnews Announces: FDA’s New Inspection Approach: What Your Inspector Knows in Four Hours Webinar, March 24, 2015 4Health News:Per Wickstrom Offers Guide to Parents for Keeping Youth Sober 2Health News:Backs in Action Receives Two Awards in The Vancouver Courier Readers’ Choice Awards 2015 2Health News:State Funds Child Abuse Helpline Housed At Georgia State 2Health News:The Makers of Liporidex, The Popular Sports Nutrition Supplement Brand, Launches Its New L-Style Revolution™ Diet & Exercise Program That Promises Turbo Charged Results 2
... Manuel Uribe Garza, thought to be the world's fattest man, had weighed ... been able to shed in just over a year as much as ... ,Seven fully grown men in all, standing in a line. That ... said to have gone out of his body! No-one knows for sure ...
... Haven, Conn. Yale Cancer Center is proud to announce the ... WNPR Connecticut Public Radio. Beginning on National Cancer Survivors Day ... to 6:30 p.m. on Sunday evenings and feature the latest ... and Ken Miller, M.D. , ,Cancer Answers is ...
... killed six people and affected 32 in a tribal-dominated Orissa ... ,All the deaths took place in Koraput district. The victims ... ,Two people from the Paraja and Sirimunda village, ... May 20 and 21, while four more succumbed later, chief ...
... the brain could help treat people who are suffering ... responding to traditional treatment. ,Thomas Schlaepfer, professor ... Germany and associate professor of psychiatry and mental health ... and his team are examining the prospects of deep ...
... developing world to look for new initiatives and programmes targeting ... many nations in the African continent are hard pressed for ... ,Like elsewhere in the third world, visitors to Zambia ... of persons walking aimlessly along the roads, talking to themselves ...
... and Onyx Pharmaceuticals, Inc. today announced that Nexavar(R) ... with hepatocellular carcinoma (HCC), or primary liver ... were presented at the 43rd annual meeting of ... ,The international, Phase 3, placebo-controlled Sorafenib HCC ...
Cached Medicine News:Health News:Worlds Heaviest Man Loses Weight Thanks to Monitored Dieting 2Health News:Yale Cancer Center Answers: A New Weekly Radio Progam on WNPR 2Health News:Implanting Electrodes in the Brain Could Help Treat Severe Depression 2Health News:Zambia Trying Hard to Tackle Crisis in Mental Health Care 2Health News:Nexavar Significantly Extends Survival of Liver Cancer Patients 2
EZ-PSA is a one-step immunoassay for the rapid, qualitative determination of human Prostate Specific Antigen (PSA) in whole blood. The test is intended for professional use as an aid in the diagnosis...
Remote Control Vision Tester Can Administer Basic,Distance Vision Tests in Less Than 2 Minutes....
... Increase profitability ... time with simple ... be administered by ... in,less than 5 ...
Vectograms are the standard for vision training. They are available in fixed or variable,styles to accommodate unlimited base-in and base-out training. Each vectogram,includes one pair,of standard 3-...
Medicine Products: