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.

About ACTEMRA

The clinical development program conducted by Roche includes five clinical studies and has enrolled more than 4,000 patients in 40 countries, including the U.S. One of these Phase III trials evaluating ACTEMRA in RA is an ongoing two-year study and is expected to report one-year data evaluating the effect of ACTEMRA on the inhibition of structural damage in 2008.

ACTEMRA is part of a co-development agreement with Chugai, a Japanese company. ACTEMRA was launched in Japan by Chugai in June 2005 as a therapy for Castleman's disease. Additional indications for RA and systemic-onset juvenile idiopathic arthritis were also filed in Japan in April 2006 and are currently under review.

The serious adverse events reported in ACTEMRA clinical trials were serious infections and hypersensitivity reactions including anaphylaxis. The most common adverse events reported in clinical studies 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.

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 and osteoporosis and may contribute to shortening life expectancy by affecting major organ systems. After 10 years, less than 50% of patients can continue to work or function normally on a daily basis. RA affects more than 21 million people worldwide with approximately 2.1 million people affected in the U.S.

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 and one of the Top 20 Employers (Science magazine). In 2006, Roche was ranked the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers, and in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or http://www.roche.us

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


'/>"/>
SOURCE Roche
Copyright©2007 PR Newswire.
All rights reserved

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:5/4/2016)... 2016 Valeritas Holdings, Inc. (OTCQB: ... public offering (APO). This was accomplished via a reverse ... and a private placement of approximately 5 million shares ... Under the terms of the reverse merger, ... Inc. will trade on the OTC Markets under the ...
(Date:5/4/2016)... 4, 2016 Research ... "Global Actinic Keratosis Market and Competitive Landscape ...      (Logo: http://photos.prnewswire.com/prnh/20160330/349511LOGO ... Competitive Landscape Highlights 2016, provides comprehensive insights ... epidemiology, Actinic Keratosis market valuations and forecast, ...
(Date:5/3/2016)... Research and Markets has announced the addition ... Outlook 2020" report to their offering. ... has improved significantly in past years due to which ... years. Many cancer drugs have been developed by utilization ... expected to be developed with its help. They are ...
Breaking Medicine Technology:
(Date:5/6/2016)... , ... May 06, 2016 , ... The International ... on the north end of the island close to the town famous for its ... 10th 2016. , “We continue to have an amazing experience in Greece, we ...
(Date:5/6/2016)... ... 2016 , ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh, has written a ... in the Bible about helping to stop cancer. Yisrayl says there are too many suffering ... the health and science industries will pay close attention and take action. The Pastor says ...
(Date:5/6/2016)... OR (PRWEB) , ... May 06, 2016 , ... This ... but for women everywhere. The 17th annual National Women’s Health Week takes ... Office on Women’s Health are combining forces to empower women to make their health ...
(Date:5/6/2016)... ... May 06, 2016 , ... RowdMap, Inc. co-founder, ... BlueShield and Former Principal Deputy Administrator at Centers for Medicare and Medicaid Services ... Ondra, MD, Chief Medical Officer at Health Care Service Corporation (Blue Cross and ...
(Date:5/5/2016)... ... 2016 , ... Pivot Point Consulting achieved the ... KLAS Performance Report, Epic Consulting 2016 - Which Firms Provide Breadth, Depth, ... services for electronic health record (EHR) solutions from Epic Systems Corporation . ...
Breaking Medicine News(10 mins):