Navigation Links
FDA Advisory Committee Recommends Approval of ACTEMRA(R) (tocilizumab) for the Treatment of Rheumatoid Arthritis
Date:7/29/2008

- First interleukin-6 (IL-6) inhibitor to offer new therapeutic option for

rheumatoid arthritis -

NUTLEY, N.J., July 29 /PRNewswire/ -- Roche today announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) by a near unanimous (10-1) vote recommended approval of ACTEMRA(R) (tocilizumab), a novel interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody, for reducing the signs and symptoms in adults with moderate to severe rheumatoid arthritis (RA).

"The committee's overwhelmingly positive recommendation brings ACTEMRA one step closer to becoming available to patients who suffer from the painful and debilitating symptoms associated with RA," said Kenneth Bahrt, M.D., Global Medical Director, Autoimmunity, Roche. "Based on the strength of the data presented, and the positive recommendation by the committee, we are hopeful that the FDA will approve ACTEMRA for the treatment of RA and provide a new option to patients who are not achieving adequate symptom relief with current therapies."

The committee's vote was made after Roche presented results from five Phase III clinical trials. The clinical development program was designed to evaluate the effects of ACTEMRA on signs and symptoms of RA, physical function, progression of structural damage, and health-related quality of life. Of these five studies, three trials were conducted in patients with inadequate response to disease modifying anti-rheumatic drugs (DMARDs), one trial was conducted in patients who failed anti-tumor necrosis factor (TNF) therapy, and one monotherapy study comparing ACTEMRA to methotrexate, a current standard of care, was also conducted. Results of these studies demonstrated that treatment with ACTEMRA -- alone or in combination with methotrexate or other DMARDs -- significantly reduced RA signs and symptoms, regardless of previous therapy or disease severity, compared with current DMARDs.

About ACTEM
'/>"/>

SOURCE Roche
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. Genaera Announces Formation of Scientific Advisory Board for Obesity Drug Candidate Trodusquemine (MSI-1436)
2. China Holdings Appoints Ronald Shon Chairman of Advisory Board to Its Wholly-Owned Subsidiary China Power, Inc.
3. CryoCor Invited to Participate in FDA Advisory Panel Meeting on Atrial Fibrillation
4. Patient Safety Authority Board of Directors Names Infection Advisory Panel
5. Broker a Suite of Research & Advisory Services to Enhance Human Resources
6. Lynn Clark Callister, National Leader in Maternal-Child Health Nursing, Joins March of Dimes Advisory Council
7. MaxLife Fund Corp. appoints Daniel E. Kahan, to its Advisory Board
8. Delta Dental Plans Association Forms National Scientific Advisory Committee
9. Alter+Care Creates the Advisory Board
10. Patient Safety Authority Releases Advisory Focusing on Common Causes of Medication Errors
11. Susan G. Komen for the Cure Appoints Dr. Amelie G. Ramirez to Scientific Advisory Board
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/26/2014)... 2014 Parker & Sons, Inc. ... in heating, cooling and plumbing contractor services throughout ... services in 2014 with regard to air-conditioning systems. ... is known for its incredibly hot summers. Working ... intricacies and details of a wide variety of ...
(Date:12/25/2014)... 2014 The click strand ... strength and durability. Today, the business announces a ... valid until Jan. 30, 2015. , Click strand ... hardwood. BambooFlooringChina.com is a well-known brand in the ... to find a reliable bamboo flooring supplier. , ...
(Date:12/25/2014)... 2014 Product liability lawsuits filed in ... ( http://www.consumerinjurylawyers.com/DePuy/ ) continue to move forward in federal ... issued in the U.S. District Court, Northern District of ... open conference on January 7, 2015, at the Paul ... West Palm Beach, Florida. The Conference is scheduled to ...
(Date:12/25/2014)... Recently, Dylan Queen, a famous online company supplying ... of discounted prom dresses, most of which are priced ... the company, the promotion is valid until Jan. 22, ... the UK market. , The prom dresses in this ... styles: A-line strapless, empire strapless chiffon, one shoulder, floor-length, ...
(Date:12/25/2014)... sells many bamboo products and the business is famous ... announces big discounts on its bamboo mats , which ... the world’s leader in bamboo flooring. According to the ... 2015. , The bamboo mats are made from well-treated ... the bamboo strips for the mats are boiled and ...
Breaking Medicine News(10 mins):Health 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 2Health News:Various Styles of Bamboo Mats in Many Colors from BambooFlooringChina.com 2
... (HealthDay News) -- A doctor,s empathy can improve the care ... of being a good doctor, according to a new study. ... 2006 and June 2009 by 29 doctors at Thomas Jefferson ... of empathy for patients, while the quality of patient care ...
... , FRIDAY, March 11 (HealthDay News) -- Watching ... a close score can be thrilling, but there may be ... A new study has found that traffic deaths at the ... significantly when the "nail-biter" game is over. Researchers at ...
... patients, insurers, industry representatives, and federal agency officials ... cancer clinical trials system at a March 21 ... American Society of Clinical Oncology. A 2010 ... for the 21st Century: Reinvigorating the NCI Cooperative ...
... 11, 2011 InDevR announced today that it has been ... the National Institutes of Health in the amount of $3 ... "Simultaneous Screening for A/H3N2, A/H1N1, A/H5N1 and B Influenza Viruses," ... platform for which influenza screening is the first targeted test. ...
... Thompson HealthDay Reporter , FRIDAY, March 11 (HealthDay ... his own when the company for which he made heat-resistant ... and his wife, who live in Battle Creek, Mich., opened ... test about 15 houses a week for radon. "It,s ...
... HealthDay Reporter , THURSDAY, March 10 (HealthDay News) ... climbed to 11.7 million in 2007, government health officials ... there were 3 million survivors, and also since 2001, when ... from the U.S. Centers for Disease Control and Prevention and ...
Cached Medicine News:Health News:Fans of Winning Teams Linked to Fatal Crashes 2Health News:Inspection Can Reveal Whether Radon Problem Exists 2Health News:Almost 12 Million Cancer Survivors Living in U.S., Report Shows 2Health News:Almost 12 Million Cancer Survivors Living in U.S., Report Shows 3
(Date:12/24/2014)... , Dec. 24, 2014 Soligenix, ... late-stage biopharmaceutical company developing products that address unmet ... and biodefense, announced today that on December 24, ... offering. The Company raised approximately $2.3 ... intends to use the net proceeds from the ...
(Date:12/24/2014)... YORK and LONDON , ... global orthopedic industry are expected to grow at an ... in terms of value and volume. Hip, knee and ... developed world while in emerging economies they have a ... rates are challenging the use of composites. Non-metallic orthopedic ...
(Date:12/24/2014)... LifeScienceIndustryResearch.com adds 2014 ... Industry of 178 pages providing 10 company ... The 2014 Market Research Report ... professional and deep research report on Global ... report introduces Disposable Syringe basic information including ...
Breaking Medicine Technology:Soligenix Announces Closing of Public Offering of Units 2Soligenix Announces Closing of Public Offering of Units 3Use of Composites in Orthopedic Industry to Reach $596 Million by 2020 2Use of Composites in Orthopedic Industry to Reach $596 Million by 2020 3World Disposable Syringe Market 2014 Report: China and Regional Analysis 2World Disposable Syringe Market 2014 Report: China and Regional Analysis 3World Disposable Syringe Market 2014 Report: China and Regional Analysis 4World Disposable Syringe Market 2014 Report: China and Regional Analysis 5
... role in national effort probing for,answers, By Joe ... Commission, NOTE: Photos to accompany the following article ... by clicking on "Release,#049-08.", HARRISBURG, Pa., May 7 ... new frontier: it is working with several,states and the ...
... 9 The risk of the two major,prostate diseases, ... changes in lifestyle, such as avoiding smoking, maintaining a,normal ... associate,head of the Cancer Prevention Program at Fred Hutchinson ... suggest men need not,feel helpless against prostate cancer or ...
Cached Medicine Technology:White Nose Syndrome: Is Pennsylvania Next? 2White Nose Syndrome: Is Pennsylvania Next? 3White Nose Syndrome: Is Pennsylvania Next? 4White Nose Syndrome: Is Pennsylvania Next? 5White Nose Syndrome: Is Pennsylvania Next? 6Preventing Prostate Cancer and BPH: Prostate-Health Expert Available (National Men's Health Week Is June 9-15) 2Preventing Prostate Cancer and BPH: Prostate-Health Expert Available (National Men's Health Week Is June 9-15) 3Preventing Prostate Cancer and BPH: Prostate-Health Expert Available (National Men's Health Week Is June 9-15) 4
... The Centra-GP6R general purpose centrifuges offer ... assortment of rotor options, making them ideal ... Maximum Versatility , Four- or ... and specialized oil tube rotors offered , ...
... designed to accommodate over 55 centrifuge tubes, ... heat labile samples. Incorporating the latest technology, ... automatic quick cooling from 22 C to ... maintenance brushless motor, low pitch 62 dBA ...
Inquire...
... MicroCentrifuge 6-Place Rotor has a standard 1.5ml rotor ... .4ml adapters. Easy operation (no switches to mess ... and press the plastic tab to open. Starts ... rpm and 2000 x g. Only five inches ...
Medicine Products: