Navigation Links
ARCALYST® (rilonacept) Meets Primary and All Secondary Endpoints in Second Phase 3 Trial for Prevention of Gout Flares in Patients Initiating Uric Acid-Lowering Therapy
Date:2/28/2011

he efficacy findings from the PRE-SURGE 1 trial demonstrating that treatment with ARCALYST reduced the incidence of such flares. With these positive Phase 3 trials in patients with gout initiating uric acid-lowering therapy, we plan to submit a supplemental Biologics License Application for U.S. regulatory approval in mid-2011."  

Regeneron also announced the results from a third Phase 3 study (RE-SURGE), which evaluated the safety of ARCALYST versus placebo over 16 weeks in 1,315 patients who were at risk for gout flares while initiating or taking uric acid-lowering drug treatment. In this study, ARCALYST® (rilonacept) was generally well tolerated, and the safety profile was consistent with that reported in the PRE-SURGE 1 and PRE-SURGE 2 studies.  Specifically, other than injection site reactions, the incidence of treatment-emergent adverse events was generally well-balanced among the 985 patients who received ARCALYST at a weekly, self-administered, subcutaneous dose of 160 mg and the 330 patients who received placebo.

In the RE-SURGE Phase 3 safety study, injection site reactions, usually considered mild, were reported more commonly with ARCALYST (15.2%) than with placebo (3.3%). Overall, the cumulative rate of infections was 20.1% in patients treated with ARCALYST and 19.1% in placebo patients.  Serious infections were reported in 0.5% of patients treated with ARCALYST and 0.9% of placebo patients. Deaths were reported for 0.3% of patients treated with ARCALYST and 0.9% of placebo patients.

In this safety study, efficacy was evaluated as a secondary endpoint, and all secondary endpoints were achieved. Compared to placebo, patients who received ARCALYST had a 71% decrease in mean number of patient-reported gout flares (p<0.0001). Compared to placebo, treatment with ARCALYST reduced the proportion of patients who reported at least one gout flare during the study period by 50% (p<0.0001) and reduced the proportion of
'/>"/>

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

Page: 1 2 3 4 5 6 7 8 9 10

Related medicine technology :

1. Mindray Medical Meets 2010 Product Development Targets and Announces Strong 2011 Pipeline
2. New IonWorks Barracuda Automated Patch Clamp System Meets Need for Affordable, Accelerated Screening of Ligand- & Voltage-Gated Ion Channels Via Direct Electrophysiology Assays
3. US Oncology Meets With Leading Pharmaceutical and Biotech Companies to Design Clinical Trials for the Cancer Fighting Drugs of Tomorrow
4. LEO Pharmas PEP005 Meets Primary Endpoint in Phase III Trial for Pre-Cancerous Skin Condition
5. Poniard Pharmaceuticals Announces Phase 2 Trial of Picoplatin in Metastatic Colorectal Cancer Meets Primary Endpoint and Study Objectives
6. Investigational Sublingual Allergy Immunotherapy Tablet Meets Primary Endpoint in a Study of Adult Subjects With a History of Grass Pollen Allergies
7. Novartis drug Tasigna(R) meets primary endpoint in pivotal trial against Gleevec(R) as first-line treatment in chronic myeloid leukemia patients
8. Intercept Pharmaceuticals FXR Agonist INT-747 Meets Primary Endpoint in a Phase II Clinical Trial in Type 2 Diabetic Patients with Nonalcoholic Fatty Liver Disease
9. Jazz Pharmaceuticals and UCB Announce Second Phase III Study of Sodium Oxybate in Patients With Fibromyalgia Meets Primary Endpoints
10. MADIT-CRT Trial Meets Primary Endpoint
11. VIA Pharmaceuticals Meets With FDA to Discuss Next Steps For VIA-2291 and Phase 3 Outcome Trial in Cardiovascular Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/2/2014)... , Sept. 2, 2014  Amgen ... the submission of a Marketing Authorization Application ... via the centralized procedure for talimogene laherparepvec ... with melanoma that is regionally or distantly ... administered as an intralesional injection that is ...
(Date:9/2/2014)... FRANCISCO, Calif. , Sept. 2, 2014   Veracyte, ... Bonnie H. Anderson , president and chief executive officer, ... Morgan Stanley Global Healthcare Unplugged Conference 2014 on Monday, September ... York . The live audio webcast and ... http://investor.veracyte.com . Please connect to the website at least ...
(Date:9/2/2014)... Redspin, Inc., a leading provider of HIPAA ... an IT security advisory specifically for senior executives in ... presiding over the most dynamic period in the history ... Redspin,s President and CEO. "The goal of our advisory ... understand why they need to elevate IT security to ...
Breaking Medicine Technology:Amgen Submits Marketing Authorization Application For Talimogene Laherparepvec To The European Medicines Agency 2Amgen Submits Marketing Authorization Application For Talimogene Laherparepvec To The European Medicines Agency 3Amgen Submits Marketing Authorization Application For Talimogene Laherparepvec To The European Medicines Agency 4Amgen Submits Marketing Authorization Application For Talimogene Laherparepvec To The European Medicines Agency 5Amgen Submits Marketing Authorization Application For Talimogene Laherparepvec To The European Medicines Agency 6Veracyte to Present at the Morgan Stanley Global Healthcare Unplugged Conference 2014 2
... importance of dedicated information management systems for radiation ... most recent version of its MOSAIQ® Oncology Information ... Systems Society,s 2012 conference (HIMSS12), Feb. 20-24, in ... comprehensive OIS that centralizes traditional radiation oncology, particle ...
... Feb. 16, 2012  Cardium Therapeutics (NYSE Amex: ... previously announced sale of 17,857,143 shares of its common ... of approximately $5.0 million, before deducting placement agent,s fees ... investors participating in the offering purchased the shares at ...
Cached Medicine Technology:Elekta Highlights Latest Version of MOSAIQ Oncology Information System at HIMSS12 Meeting 2Cardium Announces Closing of $5.0 Million Equity Financing 2Cardium Announces Closing of $5.0 Million Equity Financing 3
(Date:9/2/2014)... 02, 2014 Humility of Mary Health Partners ... at St. Elizabeth Health Center, 1044 Belmont Ave. , The ... more than 200 common health problems as well as tips ... injury, and advice on when to seek medical attention. ... in the Youngstown Room; the evening session runs from 5:30 ...
(Date:9/2/2014)... is pleased to announce that the following papers ... the ESC Congress 2014, taking place in Barcelona, ... Ultrathin strut biodegradable polymer sirolimus-eluting stent versus ... (BIOSCIENCE): a randomised, single-blind, non-inferiority trial, Windecker et ... strut thickness, surface polymer, and drug release have ...
(Date:9/2/2014)... Researchers in New Delhi, India have published a ... exposed to asbestos-contaminated work clothes for just 3 months as ... report in a new article. Click here to read ... say their patient was diagnosed with mesothelioma after ... she had come in contact with her miner father’s dirty ...
(Date:9/2/2014)... Headaches, both chronic and acute ruin lives. ... family and friends, sleeping and just coping well with daily ... of disability worldwide. The medications prescribed for these conditions ... of these cases of headache and back pain are of ... will not detect and fix the cause. , When ...
(Date:9/2/2014)... 2014 B. E. Smith, the only ... has been retained to lead a national chief ... Hospital in Sioux Falls, S.D. The top executive ... has recently placed more than 900 healthcare executives into ... physician-owned healthcare provider and nationally recognized leader in patient-centered ...
Breaking Medicine News(10 mins):Health News:HMHP Offers ‘Health at Home’ Workshop 2Health News:The Lancet: European Society of Cardiology Congress 2014 media alert 2Health News:New Report Illustrates That Even Brief Asbestos Exposure Can Trigger Mesothelioma, According to Surviving Mesothelioma 2Health News:Physical Therapists in Houston Learn Pain Relief Techniques 2Health News:Sioux Falls Specialty Hospital Retains B. E. Smith to Recruit New CEO 2Health News:Sioux Falls Specialty Hospital Retains B. E. Smith to Recruit New CEO 3
... June 16 The famed nonprofit Los Angeles,Jewish Home ... program designed to address one of the major health ... Jewish Community Foundation,the largest manager of charitable assets for ... prevention and fitness program becomes part of the care,the ...
... 2008 Researchers at Ben-Gurion University of the Negev ... recognition system, tested at a Washington, D.C. hospital, that ... by motioning instead of touching a screen, keyboard or ... to a just released article. , The June article," ...
... from the Swedish medical university Karolinska Institute (KI) suggests that ... on if adults decide to have sex with persons of ... the individual,s unique experiences have the strongest influence on our ... in the world so far and was performed in collaboration ...
... injury-related deaths, the gap between black and white American ... at the Johns Hopkins Bloomberg School of Public Health. ... deaths among blacks ages 15 to 24 decreased, while ... in the June, 2008, edition of Injury Prevention ...
... partners, innovative use of Microsoft technology to exceed ... customer expectations and solve business problems., ... delivered exemplary solutions to customers, Microsoft Corp. today,announced ... Partner of the,Year Awards. The awards honor Microsoft ...
... PLM Based on Dassault Systemes, Newly,Introduced V6 Platform and Intercim,s ... ... PAUL, Minnesota, June 16 Intercim LLC, a global,leader in ... regulated industries and Dassault,Systemes (DS) (Nasdaq: DASTY; Euronext Paris: #13065, ...
Cached Medicine News:Health News:Los Angeles Jewish Home Institutes New Fall Prevention Program With Jewish Community Foundation Grant 2Health News:Los Angeles Jewish Home Institutes New Fall Prevention Program With Jewish Community Foundation Grant 3Health News:Gesture interface device developed by Ben-Gurion University of the Negev 2Health News:Racial disparities reduced in injury related mortality 2Health News:Microsoft Announces 2008 Partner of the Year Awards Finalists and Winners 2Health News:Microsoft Announces 2008 Partner of the Year Awards Finalists and Winners 3Health News:Microsoft Announces 2008 Partner of the Year Awards Finalists and Winners 4Health News:Microsoft Announces 2008 Partner of the Year Awards Finalists and Winners 5Health News:Microsoft Announces 2008 Partner of the Year Awards Finalists and Winners 6Health News:Microsoft Announces 2008 Partner of the Year Awards Finalists and Winners 7Health News:Intercim and Dassault Systemes Sign Memorandum of Understanding 2Health News:Intercim and Dassault Systemes Sign Memorandum of Understanding 3
...
The Tew cranial/spinal retractor is designed for posterior fossa or intraspinal microsurgery where retraction is required. Clinical applications are: Posterior fossa microsurgery and intraspinal micr...
The Doro Halo retractor system is designed for all neurosurgical applications where retraction of the brain tissue and an armrest is required....
The Budde Halo brain retractor is designed for use in all intercranial procedures where retraction of delicate brain tissue is required....
Medicine Products: