Navigation Links
Roche and FDA Agree on Pathway Towards U.S. Approval of ACTEMRA(R) (tocilizumab)
Date:12/3/2008

he future of ACTEMRA and is committed to making this important new therapy available to patients with RA."

Roche submitted the BLA for ACTEMRA to the FDA on November 18, 2007. The BLA for ACTEMRA is based on the results of an extensive multi-national clinical development program, which included more than 4,000 patients in 41 countries, including the U.S. These studies demonstrated that treatment with ACTEMRA - alone or combination with methotrexate or other DMARDs (disease modifying anti-rheumatic drugs) - significantly reduced RA signs and symptoms, regardless of previous therapy or disease severity, compared with DMARDs alone. On July 29, 2008, the Arthritis Advisory Committee of the FDA voted 10-1 to recommend approval of ACTEMRA.

On December 3, 2008, the Swiss authorities approved RoActemra (tocilizumab, known as ACTEMRA outside the EU) for the treatment of moderately severe to severe, active rheumatoid arthritis in adult patients who did not respond adequately to treatment with DMARDs or tumor necrosis factor (TNF) inhibitors. RoActemra can be administered as a monotherapy or in combination with methotrexate and/or other conventional DMARDs. There are no significant post-approval commitments required.

On November 21, 2008, Roche announced that the European Committee on Human Medicinal Products (CHMP) provided a positive recommendation for RoActemra. This recommendation is for use of RoActemra in combination with methotrexate for the treatment of adult patients with moderate to severe RA who have either responded inadequately to, or who were intolerant to, previous therapy with one or more DMARDs or TNF antagonists. In these patients, RoActemra can be given as monotherapy in cases of intolerance to methotrexate or where continued treatment with methotrexate is inappropriate.

About ACTEMRA(R) (tocilizumab)

ACTEMRA i
'/>"/>

SOURCE Roche
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Roche, InterMune and Pharmasset Announce Initiation of INFORM-1, the First Dual-Combination Clinical Trial with Oral Antivirals in Hepatitis C
2. Memory Pharmaceuticals and Roche Expand R3487/MEM 3454 Development Program
3. National Jewish Health and Roche Diagnostics Corporation Reach Agreement to Pursue Environmental Molecular Diagnostics Opportunities
4. MacroChem Announces Phase 2 Data for EcoNail(R) in the Treatment of Onychomycosis
5. University of Rochester Researcher Named Millennium Pharmaceuticals Career Development Scholar of The Leukemia & Lymphoma Society
6. Roche Moves Investigational Diabetes Drug, Taspoglutide, Into Phase III Clinical Trials
7. New Roche Data to be Presented at ASCO Offers Further Hope for Cancer Patients
8. Roche Exercises its Option to Further Develop and Commercialize Memory Pharmaceuticals Nicotinic Alpha-7 Agonist, MEM 3454
9. Roche Gains Access to Important Oncology Target With Potential for Treating Major Cancers Such as Breast and Lung; First Drug Candidate in Phase I Clinical Testing
10. MacroChem Announces Presentation of Pexiganan Phase 3 Study Results for Topical Treatment of Diabetic Foot Infection
11. Memory Pharmaceuticals & Roche Expand Development Program for MEM 3454 in Schizophrenia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/25/2014)... Oct. 24, 2014  Heska Corporation (Nasdaq: ... You to Join Its Third Quarter 2014 Earnings Conference ... a.m. (MDT) / 11:00 a.m. (EDT)Where: , www.heska.com ... on the front page of this website)How:Live over the ... the address above.  Alternatively, you may use the following ...
(Date:10/25/2014)... , Oct. 24, 2014  The National Association ... latest results achieved by Kentucky,s ... The National Precursor Log Exchange (NPLEx) ... point of sale and helps flag meth offenders ... often set up NPLEx "watch lists" that notify ...
(Date:10/25/2014)... 2014   Metanome, Inc. , a ... data analysis, was the genomic sequencing provider for Seres ... clinical trial of SER 109, an Ecobiotic® therapeutic for ... infections (CDI). Metanome has provided genomic ... clinical programs. Such genomic characterization has enabled the study ...
Breaking Medicine Technology:Webcast Alert: Heska Announces Third Quarter 2014 Earnings Conference Call Webcast 2Kentucky's NPLEx Technology Making Significant Progress 2Metanome Selected as Metagenomics Provider for Seres Health Clinical Trial 2
... 2, 2012  Arena Pharmaceuticals, Inc. (NASDAQ: ARNA ... Marketing Authorization Application (MAA) with the European Medicines Agency ... weight control, including weight loss and maintenance of weight ... patients who are overweight (BMI >27) and have at ...
... 2012 /PRNewswire-Asia-FirstCall/ -- Concord Medical Services Holdings Limited ("Concord ... leading specialty hospital management solution provider and operator ... imaging centers in China, today announced it will release ... full year 2011 after the market closes, at ...
Cached Medicine Technology:Arena Pharmaceuticals Files European Marketing Authorization Application for Lorcaserin for Weight Control 2Arena Pharmaceuticals Files European Marketing Authorization Application for Lorcaserin for Weight Control 3Arena Pharmaceuticals Files European Marketing Authorization Application for Lorcaserin for Weight Control 4Concord Medical to Report Fourth Quarter and Full Year 2011 Financial Results on March 21, 2012 2
(Date:10/25/2014)... (PRWEB) October 25, 2014 Background: , ... Recovery (CCAR). He is a pioneer in the field of ... in Connecticut's state treatment system and when he retired, he ... him while in public service. , 1. ... critical decisions concerning them? , 2. Can the recovery ...
(Date:10/25/2014)... 25, 2014 Market Research ... Industry, 2009-2019 is a professional and in-depth ... Diagnostics industry. The report firstly reviews the ... classification, application and manufacturing technology. The report ... of Molecular Diagnostics listing their product specification, ...
(Date:10/25/2014)... 2014 The federal judge overseeing ... ) filed against Boston Scientific Corp. in the ... Southern District of West Virginia has denied a ... in a group of cases filed on behalf ... October 21st, U.S. District Judge Joseph R. Goodwin ...
(Date:10/25/2014)... Oct. 24, 2014 (HealthDay News) -- Interrupting blood supply to ... reduce the risks associated with the surgery, according to a ... stop the blood supply to the heart to be able ... the heart will reduce its ability to produce energy because ... flow to another large muscle, such as an arm or ...
(Date:10/25/2014)... Researchers who discovered antibiotics in farmed and wild ... The use of antibiotics in animals, including ... to the development of antibiotic-resistant bacteria that threaten ... study. Each year in the United States, ... kill about 23,000, according to the Infectious Diseases ...
Breaking Medicine News(10 mins):Health News:CCAR Accepting Nominations for the Bob Savage Recovery Advocate of the Year Award 2Health News:Global and China Molecular Diagnostics Industry Analysis to 2019 is Now Available at RnRMarketResearch.com 2Health News:Global and China Molecular Diagnostics Industry Analysis to 2019 is Now Available at RnRMarketResearch.com 3Health News:Global and China Molecular Diagnostics Industry Analysis to 2019 is Now Available at RnRMarketResearch.com 4Health News:Transvaginal Mesh Lawsuits Move Forward, As Federal Judge Denies Motion for Summary Judgment on Punitive Damages in Florida Cases, Bernstein Liebhard LLP Reports 2Health News:Transvaginal Mesh Lawsuits Move Forward, As Federal Judge Denies Motion for Summary Judgment on Punitive Damages in Florida Cases, Bernstein Liebhard LLP Reports 3Health News:Transvaginal Mesh Lawsuits Move Forward, As Federal Judge Denies Motion for Summary Judgment on Punitive Damages in Florida Cases, Bernstein Liebhard LLP Reports 4Health News:Brief Interruption of Blood Supply to Limb Might Aid Heart Surgery: Study 2Health News:Researchers Say Antibiotics in Fish a Health Concern 2
... is not a luxury;,it is an activity that is ... survey analysis of 30 companies and in-depth interviews,with seven ... in a,difficult economy., The complete study addresses areas ... goals of benchmarking studies, how companies are,demonstrating value through ...
... chemical serotonin influences fat metabolism , , THURSDAY, June 5 ... a frustrating truism familiar to the diet-conscious choosing between ... weight control isn,t just a matter of what you ... system is genetically predisposed to process fat. , The ...
... Forum to Explore Solutions Presented by The Massachusetts ... 5 "We are greatly,concerned in this state about ... of our returning veterans, the stress, depression and ... specter of rising levels of,domestic violence and suicide. ...
... The U. S. Army Corps of,Engineers, in partnership ... and recreation industry partners, will,participate in the first ... On this day, more than 75 organizations will ... privately-managed recreation sites,across the country according to event ...
... and ... more, ... and figure competitors Allison,Frahn and Tina Durkin, will represent GNC at the ... in Atlanta., Chad, part of the World Natural Bodybuilding Federation (WNBF), ...
... top equine veterinarians perform leading-edge techniques and,identify ... lives of both,horses and humans, WASHINGTON, ... Research (FBR) releases its feature film Majestic ... Dr. Larry Bramlage (Rood & Riddle,Equine Hospital) ...
Cached Medicine News:Health News:Demonstrating the Value of Benchmarking in an Uncertain Economy 2Health News:Weight Gain May Not Be Based Just on What You Eat 2Health News:Weight Gain May Not Be Based Just on What You Eat 3Health News:Growing Public Health Crisis of Domestic Violence and Suicides by Returning Veterans 2Health News:Army Corps of Engineers Will Host National Get Outdoors Day Activities at Six Corps Project Sites 2Health News:Rite Aid Health and Beauty Expo to Showcase GNC Athletes 2Health News:The Foundation for Biomedical Research (FBR) Releases Feature DVD Majestic for World Premiere 2