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:12/24/2014)...  The International Trade Commission (ITC) issued its final decision ... In a notice issued on December 23, the ITC ruled ... its humidifier was invalid. BMC President, James ... very excited with the ITC,s decision in this case. This ... since the very beginning on the key patents in the ...
(Date:12/24/2014)... and FARMINGTON, Conn. , ... (NYSE MKT: PTN), a biopharmaceutical company developing targeted, ... with significant unmet medical need and commercial potential, ... private placement of 2,050,000 shares of its common ... shares of its common stock.  Funds under the ...
(Date:12/24/2014)... , Dec. 23, 2014 Echo Therapeutics, ... device company focused on skin permeation, continuous glucose ... Scott W. Hollander has been appointed Chief ... has more than 20 years of experience in ... and most recently served as Vice President, Business ...
Breaking Medicine Technology:ITC Final Decision Goes Against ResMed (RMD) Monumental Win for 3B/BMC 2Palatin Completes $20 Million Equity and $10 Million Debt Financings 2Palatin Completes $20 Million Equity and $10 Million Debt Financings 3Palatin Completes $20 Million Equity and $10 Million Debt Financings 4Echo Therapeutics Announces Scott W. Hollander as President & Chief Executive Officer 2Echo Therapeutics Announces Scott W. Hollander as President & Chief Executive Officer 3
... and AVENTURA, Fla., Dec. 17, 2010 This week, ... Medical Cancer Center, using cranes to set in place ... Temporary Radiotherapy Vault (TRV) by RAD Technology Medical Systems ... Once complete, this "temporary vault" will allow ...
... 2010 In response to the growing cholera epidemic ... is donating $1.5 million to the Pan American Health ... fluids and other essential supplies. (Logo: ... the number of cholera cases in Haiti has now ...
Cached Medicine Technology:Olympic Medical Cancer Center Installs Temporary Radiation Oncology Facility 2Red Cross Supports Pan American Health Organization with $1.5 Million in Medicine and Supplies for Cholera Response 2
(Date:12/26/2014)... FL (PRWEB) December 26, 2014 India ... health insurance in the USA, announced today a new ... assist members in choosing the right plan for their ... the complexity out of the selection process when choosing ... by age group with only a few clicks. Many ...
(Date:12/26/2014)... AZ (PRWEB) December 26, 2014 ... source for the best in heating, cooling and ... for 24 hour emergency services in 2014 with ... alike know that Arizona is known for its ... company that understands the intricacies and details of ...
(Date:12/25/2014)... The click strand woven ... and durability. Today, the business announces a click ... until Jan. 30, 2015. , Click strand woven ... BambooFlooringChina.com is a well-known brand in the bamboo ... find a reliable bamboo flooring supplier. , “We ...
(Date:12/25/2014)... York (PRWEB) December 25, 2014 Product ... DePuy ASR hip recall ( http://www.consumerinjurylawyers.com/DePuy/ ) continue to ... According to an Order issued in the U.S. District ... Court will convene an open conference on January 7, ... United States Courthouse in West Palm Beach, Florida. The ...
(Date:12/25/2014)... 2014 Recently, Dylan Queen, a famous ... released its collection of discounted prom dresses, most of ... senior spokesman of the company, the promotion is valid ... is to expand the UK market. , The prom ... colors, lengths, and styles: A-line strapless, empire strapless chiffon, ...
Breaking Medicine News(10 mins):Health News:India Network Health Insurance Announces new Comprehensive Pre-existing Condition Coverage policy for Visitors to the United States 2Health News:India Network Health Insurance Announces new Comprehensive Pre-existing Condition Coverage policy for Visitors to the United States 3Health News:Parker & Sons Announces Record Demand For 24 Hour Emergency Services In 2014 With Regard To Air-Conditioning Systems 2Health News:Parker & Sons Announces Record Demand For 24 Hour Emergency Services In 2014 With Regard To Air-Conditioning Systems 3Health News:BambooFlooringChina.com: click strand woven bamboo flooring promotion valid until Jan. 30, 2015. 2Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 2Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 3Health News:Dylan Queen: Cheap Prom Dresses for the UK Market 2
... Gamma secretase modulators,(GSMs) have shown promise in ... research conducted by TorreyPines Therapeutics, Inc.,(Nasdaq: ... Ph.D., the company,s Chief Scientific,Officer, at the ... that GSMs provide a more selective mechanism ...
... Update on Product Approval Pipeline, SHENZHEN, China, ... MR ) today announced it has received ... Administration ("FDA") for,its portable M5 ultrasound imaging system ... received FDA 510(k) clearance,for a total of 14 ...
... Grants to Benefit Prevention, Control Efforts in Every,County, ... benefit from an aggressive effort to monitor and control,mosquitoes ... he,announced a $5.3 million investment that will help fight ... over the past several years to protect the,public,s health ...
... Bikes for meetings, errands, exercise., - Reduce pollution, ... Museum will add,to its already extensive "green" record by ... - just in time for spring., The Museum ... to bicycle to work by providing showers and bike ...
... Home Residents Not Adequate, HARRISBURG, Pa., March 31 ... on SSI pay $1096 month,for their room and board. ... $60 to cover all of their personal needs. Despite ... since 1993., Advocates for personal care home residents ...
... Wash., March 31 Cardiac Science,Corporation (Nasdaq: ... advanced cardiac diagnosis,resuscitation, rehabilitation, and informatics products, ... Cardiology conference that it completed,certification for its ... Systems. NextGen is a leading developer and ...
Cached Medicine News:Health News:Gamma Secretase Modulators Show Promise in Alzheimer's Disease Animal Model Efficacy Studies, According to Research Conducted by TorreyPines Therapeutics 2Health News:Gamma Secretase Modulators Show Promise in Alzheimer's Disease Animal Model Efficacy Studies, According to Research Conducted by TorreyPines Therapeutics 3Health News:Mindray's Laptop-size M5 and BS-200 Receive FDA Clearance 2Health News:Mindray's Laptop-size M5 and BS-200 Receive FDA Clearance 3Health News:Mindray's Laptop-size M5 and BS-200 Receive FDA Clearance 4Health News:Governor Rendell Proposes County Grants to Combat West Nile Virus, Protect Public Health 2Health News:Governor Rendell Proposes County Grants to Combat West Nile Virus, Protect Public Health 3Health News:Governor Rendell Proposes County Grants to Combat West Nile Virus, Protect Public Health 4Health News:Governor Rendell Proposes County Grants to Combat West Nile Virus, Protect Public Health 5Health News:Field Museum Launches Shared Bike Program for Employees 2Health News:Cardiac Science Adds NextGen to Its Roster of Certified EMR System Partners 2Health News:Cardiac Science Adds NextGen to Its Roster of Certified EMR System Partners 3Health News:Cardiac Science Adds NextGen to Its Roster of Certified EMR System Partners 4
... for LASIK surgery and other types ... the corneal interface and/or stromal bed. ... the flap and helps elevate the ... irrigation. 23G x 7/8in (.60 x ...
... designed for LASIK surgery and other ... irrigate the corneal interface and/or stromal ... under the flap and helps elevate ... multi-directional irrigation. 21G x 7/8in (.80 ...
For injecting viscoelastic to all meridians of the anterior chamber and to coat intraocular lenses. 20G x 7.8in (.90 x 22mm)....
Cannula tip is specially rounded, extra smooth for safe insertion through wound and manipulation in the anterior chamber. 23G x 7/8 in (.60 x 22mm). .3mm end port. Olive shape tip is 2mm long x 1mm w...
Medicine Products: