Navigation Links
FDA Advisory Committee Recommends Approval of ACTEMRA(R) (tocilizumab) for the Treatment of Rheumatoid Arthritis

- 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 ACTEMRA (tocilizumab)

ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody. Studies suggest 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 extensive clinical development program conducted by Roche includes five clinical studies and has enrolled more than 4,000 patients in 41 countries, including the United States. Five Phase III studies are completed and have reported meeting their primary endpoints. The LITHE trial evaluating ACTEMRA in RA is an ongoing two-year study and is expected to report complete data evaluating the effects of ACTEMRA on the inhibition of structural joint damage in 2009. ACTEMRA is awaiting approval in the United States and Europe.

ACTEMRA is part of a co-development agreement with Chugai, a Japanese company. In June 2005, ACTEMRA was launched by Chugai in Japan as a therapy for Castleman's disease; in April 2008, additional indications for rheumatoid arthritis, juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis were also approved in Japan.

The serious adverse events reported in ACTEMRA clinical trials include serious infections, diverticular perforations, and hypersensitivity reactions including anaphylaxis. The most common adverse events reported in clinical trials were upper respiratory tract infection, nasopharyngitis, headache and hypertension. Increases in liver function tests (ALT and AST) were seen in some patients; these increases were generally mild and reversible, with no hepatic injuries or any observed impact on liver function. Laboratory changes, including increases in lipids (total cholesterol, LDL, HDL, triglycerides) and decreases in neutrophils and platelets, were seen in some patients without association with clinical outcomes.

About IL-6

IL-6 is a common protein found in all joints in the body and is a natural substance that can raise inflammation. Everyone has IL-6 in their body, but people with RA may have too much. If approved, ACTEMRA will be the first and only medication to specifically target IL-6 in patients with RA.

About Rheumatoid Arthritis

Rheumatoid arthritis is a progressive, systemic autoimmune disease characterized by inflammation of the membrane lining in the joints. This inflammation causes a loss of joint shape and function, resulting in pain, stiffness and swelling, ultimately leading to irreversible joint destruction and disability. Characteristics of RA include redness, swelling, pain and movement limitation around joints of the hands, feet, elbows, knees and neck that leads to loss of function. In addition, the systemic symptoms of RA include fatigue, decreased hemoglobin, osteoporosis and may contribute to shortening life expectancy by affecting major organ systems. After 10 years, less than 50 percent of patients can continue to work or function normally on a daily basis. RA affects more than 21 million people worldwide with approximately 1.3 million adults affected in the United States.

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years in the U.S., Roche has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2007 Roche was named Top Company of the Year by Med Ad News, one of the Top 20 Employers (Science) and ranked the No. 1 Company to Sell For (Selling Power). In previous years, Roche has been named as a Top Company for Older Workers (AARP) and one of the Best Companies to Work For in America (Fortune). For additional information about the U.S. pharmaceuticals business, visit our website: Product and treatment information for U.S. healthcare professionals is available at

All trademarks used or mentioned in this release are protected by law.

Copyright©2008 PR Newswire.
All rights reserved

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:
(Date:11/25/2015)... ... November 25, 2015 , ... ... sauna parts and accessories. , Sauna accessories help improve the bather experience in ... personality. From basic styles for the purist looking for simplicity in design to ...
(Date:11/25/2015)... ... 26, 2015 , ... Ministers, senior government and UN agencies, ... Centres of Excellence, and public R&D institutions, civil societies and other partners gathered ... 5th African Network for Drugs and Diagnostics Innovation, ANDI, Stakeholders Meeting. The three- ...
(Date:11/25/2015)... ... November 25, 2015 , ... For the first time, ... Two Organizations, One Beat ” campaign. The partnership between the two groups began in ... in MAP International’s cause. , MAP International was founded in 1954 and is an ...
(Date:11/25/2015)... FL (PRWEB) , ... November 25, 2015 , ... ... center, is encouraging people across the country to celebrate their sobriety and show ... people to post “before and after” photos this Thanksgiving with the hashtag #FacesOfGratitude ...
(Date:11/25/2015)... (PRWEB) , ... November 25, 2015 , ... On November ... training center for the Narconon network, announced the release of a new cutting edge ... the Narconon organization has been working with drug- and alcohol-addicted individuals with the purpose ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... , 26 november 2015 ... kondigt de geplande investering aan van ten ... de laboratoria en het mondiale hoofdkantoor in ... uitbreiding zal resulteren in extra kantoorruimte en ... aan de groeiende behoeften van de farmaceutische ...
(Date:11/26/2015)... UTRECHT , Nederland, November 26, 2015 ... --> Een nieuwe aanpak combineert ... van gevorderde kanker. ... -->      (Photo: ... van het Leids Universitair Medisch Centrum (LUMC) ...
(Date:11/26/2015)... 26, 2015 Research and Markets ( ) ... Pacemaker Market Outlook to 2019 - Rise in Cardiac Disorders ... report to their offering. Boston ... Boston scientific and others. --> ... Biotronik, Boston scientific and others. ...
Breaking Medicine Technology: