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

drug-induced Gout Exacerbations) study was a double-blind, placebo-controlled study which evaluated the number of gout flares per patient over the first 16 weeks following initiation of allopurinol therapy.  Patients who received ARCALYST at a weekly, self-administered, subcutaneous dose of 160mg had a 72% decrease in mean number of gout flares (p<0.0001) and patients who received the 80mg dose had a 72% decrease compared to the placebo group (p<0.0001).

Overall in PRE-SURGE 2, the cumulative rate of infections was 27.4% in patients treated with ARCALYST 160mg, 28.0% in patients treated with ARCALYST 80mg, and 25.6% in placebo patients.  No deaths were reported in this study.

In both trials, a gout flare was defined as patient-reported acute articular pain typical of a gout attack that was deemed (by the patient and/or the investigator) to require treatment with an anti-inflammatory therapeutic and involved at least three of four signs/symptoms (joint swelling, redness, tenderness, and pain) and one or more of the following: rapid onset of pain, decreased range of motion, joint warmth, or other symptoms similar to a prior gout flare.

The global RE-SURGE (REview of Safety Using Rilonacept in preventing Gout Exacerbations) study was a double-blind, placebo-controlled study primarily focused on evaluation of safety.  A total of 1315 patients who were at risk for gout flares because they were initiating or taking uric acid-lowering drug treatment were randomly assigned in a 1:3 ratio to receive either weekly placebo injections for 16 weeks or weekly subcutaneous injections of ARCALYST dosed at 320mg as an initial loading dose and 160mg thereafter for a total of 16 weeks.  In this trial, a gout flare was defined as patient-reported acute articular pain typical of a gout attack that was deemed (by the patient and/or the investigator) to require treatment with an anti-
'/>"/>

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:7/1/2015)... MENLO PARK, Calif. , July 1, 2015 /PRNewswire/ ... of its previously announced underwritten public offering of 3,636,364 ... the public of $2.75 per share. BioPharmX has granted ... 545,454 additional shares of common stock at the public ... Overseas Expansion Platform Fund, an existing stockholder, has agreed ...
(Date:7/1/2015)... , July 1, 2015 ... is expected to reach USD 49,119.2 million by 2020, ... Inc. Monitoring services is expected to remain the dominant ... USD 1,227.5 million in 2012, and an estimated CAGR ... (Logo: http://photos.prnewswire.com/prnh/20150105/723757 ) , Browse full ...
(Date:7/1/2015)... July 1, 2015 The Haselmeier ... Board. Mr. Gert Weber has been nominated ... as Chief Executive Officer (CEO) of the ... st , 2015. Mr. Weber brings more than 20 ... and has filled various executive management positions, the last ...
Breaking Medicine Technology:BioPharmX Corporation Closes Underwritten Public Offering of Common Stock 2BioPharmX Corporation Closes Underwritten Public Offering of Common Stock 3mHealth Market Worth $ 49,119.2 Million By 2020: Grand View Research, Inc. 2mHealth Market Worth $ 49,119.2 Million By 2020: Grand View Research, Inc. 3mHealth Market Worth $ 49,119.2 Million By 2020: Grand View Research, Inc. 4mHealth Market Worth $ 49,119.2 Million By 2020: Grand View Research, Inc. 5Haselmeier Group Announces the Extension and Reorganization of its Executive Board 2
... June 14 Codexis, Inc. (Nasdaq: CDXS) today ... received the Ernst & Young Entrepreneur Of The Year ® 2010 ... , , ... LLP, the award recognizes outstanding entrepreneurs who are building and leading dynamic, ...
... , June 14 /PRNewswire-Asia/ -- Chindex International, Inc.,(Nasdaq: CHDX ... the People,s Republic of China , today announced,financial results for the ... , Financial Highlights:, -- Revenue of ... income up 76.6% year over year to $14.4 million in the fiscal, ...
Cached Medicine Technology:Codexis CEO Alan Shaw Named Ernst & Young Entrepreneur Of The Year® 2010 Recipient in Northern California 2Codexis CEO Alan Shaw Named Ernst & Young Entrepreneur Of The Year® 2010 Recipient in Northern California 3Chindex International, Inc. Reports Fourth Quarter and Full Year Fiscal 2010 Financial Results 2Chindex International, Inc. Reports Fourth Quarter and Full Year Fiscal 2010 Financial Results 3Chindex International, Inc. Reports Fourth Quarter and Full Year Fiscal 2010 Financial Results 4Chindex International, Inc. Reports Fourth Quarter and Full Year Fiscal 2010 Financial Results 5Chindex International, Inc. Reports Fourth Quarter and Full Year Fiscal 2010 Financial Results 6Chindex International, Inc. Reports Fourth Quarter and Full Year Fiscal 2010 Financial Results 7Chindex International, Inc. Reports Fourth Quarter and Full Year Fiscal 2010 Financial Results 8Chindex International, Inc. Reports Fourth Quarter and Full Year Fiscal 2010 Financial Results 9Chindex International, Inc. Reports Fourth Quarter and Full Year Fiscal 2010 Financial Results 10Chindex International, Inc. Reports Fourth Quarter and Full Year Fiscal 2010 Financial Results 11Chindex International, Inc. Reports Fourth Quarter and Full Year Fiscal 2010 Financial Results 12Chindex International, Inc. Reports Fourth Quarter and Full Year Fiscal 2010 Financial Results 13Chindex International, Inc. Reports Fourth Quarter and Full Year Fiscal 2010 Financial Results 14
(Date:7/1/2015)... , ... July 01, 2015 , ... ... Task Force, contributing to newly released white paper: “Pro-actively Identifying the High-Cost Patient ... published July 1st and is available at: http://www.hcttf.org/resouces-tools . , The Healthcare ...
(Date:7/1/2015)... ... July 01, 2015 , ... Franklin University, one of the leading ... King has been named Dean of the College of Health & Public ... promote and support the vision and mission of Franklin University via curriculum planning, course ...
(Date:7/1/2015)... ... July 01, 2015 , ... Bunion Bootie, ... Customers purchasing two or more Bunion Booties directly from their website, ... Bootie temporarily corrects misaligned toes and its ultra thin properties allow for protection ...
(Date:7/1/2015)... ... July 01, 2015 , ... B. E. Smith, the only ... a national chief nursing officer recruitment for Capital Health in ... industry, B. E. Smith has recently placed more than 1,000 healthcare executives into organizations. ...
(Date:7/1/2015)... ... ... Who doesn’t want a life filled with thriving positivity and high-life satisfaction? Do ... life, and positive friendships and relationships? , Dr. Marsha W. Snyder explains how ... , With a focus on solving the epidemic of ill-being in the medical profession, ...
Breaking Medicine News(10 mins):Health News:A Population Based Approach to Pay for Value: RowdMap, Inc. Contributes to Health Care Transformation Task Force White Paper 2Health News:A Population Based Approach to Pay for Value: RowdMap, Inc. Contributes to Health Care Transformation Task Force White Paper 3Health News:Franklin University Appoints Dean of College of Health & Public Administration 2Health News:Bunion Bootie, the #1 Non-Surgical Treatment for Bunion Pain, Announces Their Big Summer Sale 2Health News:Capital Health Retains B. E. Smith to Recruit New Chief Nursing Officer 2Health News:Capital Health Retains B. E. Smith to Recruit New Chief Nursing Officer 3Health News:Medical Doctor Explains The Healthy Effects of a Positive Outlook in New Book 2
... July 9 According to Families USA, between 2007 and ... the age of 65 went without health insurance. In ... everyday Americans, on July 13, 2009, Teva Pharmaceuticals USA, the ... increasing healthcare access in Chicago, Illinois. The event will be ...
... , CHICAGO, July 9 Just three months before 45,000 ... Society Charity Runner Team is still offering entries to the ... "The Society is thrilled to offer the running community these ... manager, fundraising resources, American Cancer Society. "The Charity Runner program ...
... CHICAGO, July 9 /PRNewswire-USNewswire/ -- Skyrocketing prescription drug prices ... percent to cut back on the basics, like food and utilities, ... AARP survey, as brand name drugs see record price increases, the ... able to pay for their medications in the coming year. ...
... Corgenix Medical Corporation (OTC Bulletin Board: CONX), a ... be exhibiting its AspirinWorks(R) Test at the XXII Congress ... Committee of the International Society on Thrombosis and Haemostasis ... 11-16 at the Boston Convention & Exhibition Center. , ...
... , HONOLULU, July 9 Specialty care physicians can ... health records and proactively providing e-consultations and treatment plan ... Permanente paper published online in the British Medical ... project at Kaiser Permanente demonstrated that specialists can take ...
... 9 Members of SEIU UHW will hold a ... Federal Building, 1301 Clay Street, to release newly obtained information showing ... officials were advised by their attorney that some of the actions ... their lawyer,s advice on how to cover them up. , ...
Cached Medicine News:Health News:Businesses, Community Leaders Invited to Come Together to Examine the Rising Cost of Healthcare 2Health News:Calling All Runners: Join the Fight Against Cancer 2Health News:High Rx Costs Hammering Illinois' 50+ Population 2Health News:Corgenix to Exhibit AspirinWorks(R) Test at 2009 ISTH Meeting 2Health News:Corgenix to Exhibit AspirinWorks(R) Test at 2009 ISTH Meeting 3Health News:Kaiser Permanente Project Proves Electronic Health Information and Care Coordination Improve Chronic Disease Management 2Health News:Kaiser Permanente Project Proves Electronic Health Information and Care Coordination Improve Chronic Disease Management 3Health News:Kaiser Permanente Project Proves Electronic Health Information and Care Coordination Improve Chronic Disease Management 4Health News:Newly Obtained Information Shows That Ousted Union Leaders Plotted and Covered Up Wrongdoing 2
Tungsten Carbide wire twister....
Designed to have a shock-absorbing force, providing less bounce or wasted force....
Osteophyte periosteal elevator for bone removing....
Angled ring curette....
Medicine Products: