Navigation Links
Roche Submits Application for FDA Approval of ACTEMRA(R) for the Treatment of Rheumatoid Arthritis
Date:11/21/2007

- ACTEMRA(R) is the first humanized interleukin-6 (IL-6)

receptor-inhibiting monoclonal antibody seeking approval to treat

rheumatoid arthritis -

NUTLEY, N.J., Nov. 21 /PRNewswire/ -- Roche announced today the submission of a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval to market ACTEMRA(R) (tocilizumab) to reduce the signs and symptoms in adults with moderate to severe rheumatoid arthritis (RA).

"The filing for ACTEMRA represents a significant milestone for Roche, and brings us another step closer to making this important therapy available to the millions of patients in the United States who suffer from the agonizing pain and debilitating effects associated with rheumatoid arthritis," said George Abercrombie, President and CEO, Hoffmann-La Roche Inc.

ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody and represents a novel mechanism of action to treat RA. Research suggests that reducing the activity of IL-6, one of several key cytokines involved in the inflammatory process, may reduce inflammation of the joints and relieve certain systemic effects of RA.

The BLA submission to the FDA is based on results from five international Phase III studies which demonstrated ACTEMRA as monotherapy or in combination with disease modifying anti-rheumatic drugs (DMARDs) such as methotrexate significantly reduced the signs and symptoms of rheumatoid arthritis as measured by ACR -- as well as achieving disease activity score (DAS) remission -- compared to DMARD therapies alone. Furthermore, patients who had previously failed anti-tumor necrosis factor (anti-TNF) treatments also showed significant improvement in signs and symptoms of RA after treatment with ACTEMRA.

Roche will file a Marketing Authorization Application (MAA) for ACTEMRA with the European Medicines Agency (EMEA) in early December.

Ab
'/>"/>

SOURCE Roche
Copyright©2007 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3

Related medicine technology :

1. Wyeths Torisel and Roche/Genentechs Avastin Will Challenge Pfizers Sutent to Become the Clinical Gold Standard for Treatment of Metastatic Renal Cell Carcinoma
2. Researchers Identify Virus Possibly Responsible for Declining Honeybee Population Using 454 Sequencing Technology from Roche
3. Rochester Medical Anti-Infection Foley Catheter Demonstrates Effectiveness in Randomized Trial
4. MacroChem Acquires Rights to Pexiganan, a Novel Topical Anti-Infective for Treatment of Diabetic Foot Infections, From Genaera
5. Roche Announces Positive Results in Solid Tumors Using Human Monoclonal Antibody Against IGF-1R (R1507)
6. Roche Diagnostics HIV Viral Load Test Used in Clinical Trials for Isentress, a New Class of HIV Drug
7. Roches Investigational Polymerase Inhibitor, Combined with PEGASYS(R) and COPEGUS(TM), Shows Potent Antiviral Activity in Treatment of Chronic Hepatitis C at Four Weeks
8. Two Pivotal Phase III Studies for Roches ACTEMRA(TM) (tocilizumab) Demonstrate Significant Improvement in Rheumatoid Arthritis Symptoms
9. BioMarin Partner AnGes MG, Inc. Submits BLA to Japanese Ministry of Health
10. Peregrine Pharmaceuticals Submits Clinical Protocol to Initiate Bavituximab Phase II Trial in Patients With Metastatic Breast Cancer
11. Vanda Pharmaceuticals Submits Iloperidone New Drug Application
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/24/2008)...gnostic Value of Circulating Tumor Cells, RARITAN...prospective,clinical trial found the number of cir...of progression-free and overall survival among met... report published in the July 1,issue of the Journ... the US, the Netherlands, and the United,Kingdom, ...
(Date:7/24/2008)... 24 /PRNewswire-USNewswire/ -- Headlines claiming ...hole story. The small scale,preliminary study tha...production, is based on recollected intake of soyf.... "This study is confounded by many,issues, thus I...al of,caution," warned Dr. Tammy Hedlund, a resear...
(Date:7/23/2008)...st Approved Systemic Therapy to Treat the Disease ...RNewswire-FirstCall/ --,Bayer HealthCare Pharmaceu...X) today announced that The New England Journal of...onstrating that Nexavar(R) (sorafenib),tablets dec... patients with,unresectable hepatocellular carcino...
(Date:7/23/2008)... Some Areas of the Body Have Greater Concentration... /PRNewswire-USNewswire/ -- Fat removed,from the l...as found to be,an excellent source of stem cells, ...eas of the body, reports a Brazilian-based study i...the official medical journal of the,American Socie...
Breaking Medicine Technology:Journal of Clinical Oncology Article Highlights CellSearch(TM) Circulating Tumor Cell Test in Treatment of Metastatic Colorectal Cancer 2Journal of Clinical Oncology Article Highlights CellSearch(TM) Circulating Tumor Cell Test in Treatment of Metastatic Colorectal Cancer 3Soyfoods Do Not Impact Sperm Count 2The New England Journal of Medicine Publishes Nexavar(R) Study Demonstrating Significant Improvement in Overall Survival in Patients With Liver Cancer 2The New England Journal of Medicine Publishes Nexavar(R) Study Demonstrating Significant Improvement in Overall Survival in Patients With Liver Cancer 3The New England Journal of Medicine Publishes Nexavar(R) Study Demonstrating Significant Improvement in Overall Survival in Patients With Liver Cancer 4The New England Journal of Medicine Publishes Nexavar(R) Study Demonstrating Significant Improvement in Overall Survival in Patients With Liver Cancer 5The New England Journal of Medicine Publishes Nexavar(R) Study Demonstrating Significant Improvement in Overall Survival in Patients With Liver Cancer 6Want a Reason to Love Your Lower Belly Fat? It's Rich in Stem Cells 2Data Show Common Allergy Tests Are Not Interchangeable 18816 1Data Show Common Allergy Tests Are Not Interchangeable 18816 2Data Show Common Allergy Tests Are Not Interchangeable 18816 3Patti LaBelle Wows Crowd at 5th Annual Lupus Foundation of America Awards Gala 18813 1Patti LaBelle Wows Crowd at 5th Annual Lupus Foundation of America Awards Gala 18813 2Patti LaBelle Wows Crowd at 5th Annual Lupus Foundation of America Awards Gala 18813 3Angiotech to participate in Bank of America Health Care Conference 5229 1Federal polar bear research critically flawed says study in INFORMS journal 3237 1Federal polar bear research critically flawed says study in INFORMS journal 3237 2
... Risk of Late Thrombosis is Minimized with Genous ... -- The efficacy of,OrbusNeich,s Genous(TM) Bio-en...g-eluting stents, while the risk of late thrombosi... an interim,analysis of post-marketing data presen...roPCR 2007 in Barcelona, Spain. , Collected from m...
... PRINCETON, N.J.--(BUSINESS WIRE)--May 23, 2007 - ...the publication of a,review validating the utility...unction of the WW domain-containing oxidoreductase...nown involvement,in breast, prostate, lung, pancre...viewed article was published in the online,edition...
Other Medicine Technology:Efficacy of OrbusNeich's Genous Bio-Engineered R Stent Compares,Favorably to Drug-Eluting Stents 2Efficacy of OrbusNeich's Genous Bio-Engineered R Stent Compares,Favorably to Drug-Eluting Stents 3Cytogen Reports Publication Validating the Utility of its,Proprietary ProChart Database 2Cytogen Reports Publication Validating the Utility of its,Proprietary ProChart Database 3Cytogen Reports Publication Validating the Utility of its,Proprietary ProChart Database 4
(Date:7/25/2008)..., N.Y., July 25 /PRNewswire-USNewswire/ -- Anthony...ality Officer and Vice President,of Strategic Plan...und, a,national foundation committed to improving ...the foundation,s Program on Health Care Quality,Im...scom.com/cgi-bin/prnh/20080725/DC28791LOGO ), Bo...
(Date:7/25/2008)...leaning products reduces lung function, increases ..., July 25 (HealthDay News) -- A clean, fresh-smell...nding on what type of cleaning and air freshening ...at exposure to cleaning products or air fresheners...(VOC) called 1,4 dicholorobenzene (1,4 DCB), can r...
(Date:7/25/2008)... Though the number of jobs created in the...anies reported a different kind of slowdown: they ...ths. , Seattle, WA (PRWEB...ed in the medical field slowed in June overall, ph...f slowdown that will be music to the ears of sales...
(Date:7/25/2008)... Corporation Executive, Robert J. Reilly, Joins Ae...thon Inc.,( http://www.aethon.com ), the leading d...ain logistics, today announced that Robert J. Reil... -- Chief Financial Officer., Reilly, who was mos...cKesson Corporation,s Specialty Pharmacy Division,...
Breaking Medicine News(10 mins):Health News:IPRO Welcomes Back Anthony Shih as Chief Quality Officer, Strategic Planning Lead 2Health News:Health Hazards in Household Cleaners Exposed 2Health News:Health Hazards in Household Cleaners Exposed 3Health News:The MedZilla Report: June 2008 Employment Outlook for Biotech/Pharma/Health 2Health News:The MedZilla Report: June 2008 Employment Outlook for Biotech/Pharma/Health 3Health News:Aethon, Inc. Names New Chief Financial Officer 2
...h world but the death rate from it is falling due ...ers from the University of Southern Denmark carrie...0,000 people between 1993 and 1999. While the prop... by around three percent annually during the six-y...
...it suicide than other people, scientists said on F...s of more than 20,000 same-sex twins who died betw...ide with the wider population. They found that the...ardless of their sex.// The findings came as a sur...
...ck, the most important thing they can do to increa...to their heart is to get help as soon as possible....tional Heart, Lung, and Blood Institute, many peop...y experience heart attack symptoms because they do...
...hown to boost vitamin D levels and now researchers...r sun exposure during childhood and early adolesce...sclerosis, according to the study. Australian inve...which is located at high latitude and has a high p...
Other Medicine News:Health News:Recognize Heart Attack Signs 2
...Ovulation Predicting Test is a qualitative immunoa...e (hLH) in human urine to predict the occurrence o...on of human luteinizing hormone (hLH). Usually, ar...rief, significant rapid increase called the "LH su...
The Shandon Cryotome SME Cryostat model is a sophisticated, top of the line cryostat that combines automated electronic advance and hands-free sectioning with fully independent specimen temperature c
The Shandon Linistat Linear Stainer is a compact answer to H&E frozen section protocols, with a footprint that fits on top of most cryostas to streamline workflow during frozen sectioning.
The Shandon Varistain Gemini is designed for high throughput, precision, safety, durability and ultimate flexibility in histology and cytology staining applications. It features load-on-demand multip
Medicine Products: