Navigation Links
Abbott Announces HUMIRA(R) (adalimumab) Approved in Japan for the Treatment of Rheumatoid Arthritis

ABBOTT PARK, Ill., April 16 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT) announced today that it has received approval from the Japanese Ministry of Health, Labour and Welfare for HUMIRA(R) (adalimumab) for the treatment of rheumatoid arthritis in patients with inadequate response to conventional therapy. This approval is the first for HUMIRA in Japan, where Abbott co-developed and will co-market HUMIRA with Eisai Co., Ltd. HUMIRA is now approved in 75 countries for rheumatoid arthritis and other autoimmune disease indications.

"The approval of HUMIRA in Japan is a significant milestone for Abbott," said Glenn Warner, vice president, Pharmaceuticals, Japan, Abbott. "This approval is both good news for Japanese patients and a significant step forward for Abbott in Japan."

HUMIRA is expected to become available to patients in Japan in the coming months, following the standard pricing approval process.

"The clinical studies of HUMIRA in Japanese patients demonstrated the efficacy and safety of this medicine," said Prof. Nobuyuki Miyasaka, M.D., Department of Collagen Disease and Rheumatology, Tokyo Medical and Dental University Graduate School of Medicine, who was involved in the development of HUMIRA for the treatment of rheumatoid arthritis in Japan.

Abbott has submitted an application for approval of HUMIRA for plaque psoriasis, and is also developing HUMIRA in Japan for Crohn's disease, ankylosing spondylitis, juvenile rheumatoid arthritis and ulcerative colitis. Eisai is co-developing and will jointly market these indications with Abbott.

More Information About Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by joint inflammation, joint pain and stiffness, which can lead to long-term joint damage. The joints most commonly affected early in the disease are the smaller joints of the fingers, feet and wrists. The elbows, knees, ankles and hips can also be affected. Although there is no cure for RA, people continue to seek treatments that help alleviate pain and inflammation and slow disease progression.

More information on RA and current treatment options can be found at

Important Safety Information

Globally, prescribing information varies; refer to the individual country product label for complete information.

Serious infections, sepsis, rare cases of tuberculosis (TB), and opportunistic infections, including fatalities, have been reported with the use of TNF antagonists, including HUMIRA. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease could predispose them to infections. Patients must be monitored closely for infections, including tuberculosis, before, during and after treatment with HUMIRA. Treatment should not be initiated in patients with active infections until infections are controlled. HUMIRA should not be used by patients with active TB or other severe infections such as sepsis and opportunistic infections. Patients who develop new infections while using HUMIRA should be monitored closely. HUMIRA should be discontinued if a patient develops a new serious infection until infections are controlled. Physicians should exercise caution when considering use of HUMIRA in patients with a history of recurring infection or with underlying conditions that may predispose patients to infections.

TNF-blocking agents have been associated with reactivation of hepatitis B (HBV) in patients who are chronic carriers of the virus. Some cases have been fatal. Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating HUMIRA.

The combinations of HUMIRA and anakinra as well as HUMIRA and abatacept is not recommended.

TNF antagonists, including HUMIRA, have been associated in rare cases with demyelinating disease and serious allergic reactions. Rare reports of pancytopenia including aplastic anemia have been reported with TNF-blocking agents. Adverse events of the haematologic system, including medically significant cytopenia have been infrequently reported with HUMIRA.

More cases of malignancies including lymphoma have been observed among patients receiving a TNF antagonist compared with control patients in clinical trials. The size of the control group and limited duration of the controlled portions of studies precludes the ability to draw firm conclusions. Furthermore, there is an increased background lymphoma risk in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates the risk estimation. During the long-term open-label trials with HUMIRA, the overall rate of malignancies was similar to what would be expected for an age-, gender- and race-matched general population. With the current knowledge, a possible risk for the development of lymphomas or other malignancies in patients treated with a TNF antagonist cannot be excluded. All patients, and in particular patients with a medical history of extensive immunosuppressant therapy or psoriasis patients with a history of PUVA treatment, should be examined for the presence of non-melanoma skin cancer prior to and during treatment with HUMIRA.

In clinical studies with another TNF antagonist, a higher rate of serious congestive heart failure (CHF) related adverse events including worsening CHF and new onset CHF have been reported. Cases of worsening CHF have also been reported in patients receiving HUMIRA. Physicians should exercise caution when using HUMIRA in patients who have heart failure and monitor them carefully. HUMIRA should not be used in patients with moderate or severe heart failure.

The most frequently reported adverse event (greater than or equal to 1/10 patients) at least possibly causally related to HUMIRA is injection site reaction (including pain, swelling, redness or pruritus). Other common adverse events (greater than or equal to 1/100 patients) at least possibly causally related to HUMIRA include lower respiratory infections (including pneumonia, bronchitis), viral infections (including influenza, herpes infections), candidiasis, bacterial infection (including urinary tract infections), upper respiratory infection, dizziness (including vertigo), headache, neurologic sensation disorders (including paraesthesias), cough, nasopharyngeal pain, diarrhea, abdominal pain, stomatitis and mouth ulceration, nausea, hepatic enzymes increased, rash, pruritus, musculoskeletal pain, pyrexia and fatigue (including asthenia and malaise).


HUMIRA is the only fully human monoclonal antibody approved for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn.s disease and plaque psoriasis (Ps) in the United States and Europe. HUMIRA is also approved for the treatment of juvenile idiopathic arthritis (JIA) in the United States, and review for JIA in Europe is ongoing. Clinical trials are underway evaluating the potential of HUMIRA in ulcerative colitis. To date, HUMIRA has been approved in 75 countries and more than 250,000 people worldwide are currently being treated with HUMIRA.

HUMIRA resembles antibodies normally found in the body. It works by blocking tumor necrosis factor alpha (TNF-alpha), a protein that, when produced in excess, plays a central role in the inflammatory responses of many immune-mediated diseases.

In the United States, HUMIRA is approved by the FDA for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA). HUMIRA can be used alone or in combination with methotrexate (MTX) or other disease-modifying anti-rheumatic drugs (DMARDs). HUMIRA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older. HUMIRA can be used alone or in combination with MTX. HUMIRA is indicated for reducing the signs and symptoms of active arthritis, inhibiting the progression of structural damage and improving physical function in patients with psoriatic arthritis. HUMIRA can be used alone or in combination with MTX or other DMARDs. HUMIRA is indicted for reducing signs and symptoms in patients with active ankylosing spondylitis. HUMIRA is indicated for reducing the signs and symptoms and inducing and maintaining clinical remission in adults with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. HUMIRA is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab. HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy of phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

In Europe, HUMIRA, in combination with MTX, is indicated for the treatment of moderate to severe, active RA in adult patients when the response to DMARDs including MTX has been inadequate, and for the treatment of severe, active and progressive RA in adults not previously treated with MTX. HUMIRA can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. HUMIRA has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function, when given in combination with MTX.

Also in Europe, HUMIRA is indicated for the treatment of active and progressive PsA in adults when the response to previous DMARD therapy has been inadequate and for the treatment of severe, active AS in adults who have had an inadequate response to conventional therapy. HUMIRA is indicated for treatment of severe, active Crohn's disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. For induction treatment, HUMIRA should be given in combination with corticosteroids. HUMIRA can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate. HUMIRA is indicated for the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA.

Abbott's Commitment to Immunology

Abbott is focused on the discovery and development of innovative treatments for immunologic diseases.

More information about HUMIRA, including full prescribing information and Medication Guide, is available on the Web site or in the United States by calling Abbott Medical Information at 1-800-633-9110 (English language only).

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 68,000 people and markets its products in more than 130 countries. Abbott employs 2,100 people in Japan with offices in Tokyo, Osaka, Fukui, and Chiba.

Abbott's news releases and other information are available on the company's Web site at

Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Abbott to Present at Bear Stearns Healthcare Conference
2. The National Center for Missing & Exploited Children, Wal-Mart, and Abbott Host Child Safety Events
3. Dow Jones Sustainability Index Again Recognizes Abbott for Continued Leadership in Business, Environmental and Social Performance
4. Abbott Declares 335th Consecutive Quarterly Dividend
5. Abbott Again Honored as Top Company for Working Moms
6. Abbotts HUMIRA(R) (adalimumab) Honored With Prestigious Galen Prize for Innovation in Patient Care
7. Abbott Hosts Conference Call for Third-Quarter Earnings
8. Abbott Broadens Use of i-STAT Handheld Blood Analyzer with CLIA Waiver Granted by FDA for CHEM8+ Test Cartridge
9. Abbott Named One of the Best Companies for Hispanics by Hispanic Business Magazine
10. Abbott Again Honored as a Leader in Diversity
11. Abbott Researchers Target Neuronal Nicotinic Receptors for Treatment of Pain and Cognition
Post Your Comments:
(Date:10/9/2015)... ... 09, 2015 , ... The American Osteopathic Foundation (AOF) has ... Education J. Michael Finley, DO, as the recipient of the 2015 W. Douglas ... on graduate medical education opportunities for osteopathic residents, and his dedication to promoting ...
(Date:10/9/2015)... ... October 09, 2015 , ... With the FCPX LUT Vibrance pack ... footage. A LUT is a Lookup Table that contains a mathematical formula for modifying ... the table. This pack comes with 60 vibrant CUBE LUT files. , ...
(Date:10/9/2015)... ... October 09, 2015 , ... Smoke alarms can save lives. In ... the risk of dying in reported home fires in half. As part of Fire ... alarms are property installed and maintained. , Half of home fire deaths result from ...
(Date:10/9/2015)... CA (PRWEB) , ... October 09, 2015 , ... Head ... Center for the elite developmental camp at the Karolyi Ranch in Huntsville, Texas on ... Katreece Stone, Head Over Heels girls team head coach and executive director, said. “It's ...
(Date:10/9/2015)... ... October 09, 2015 , ... The Asthma and Allergy Foundation ... for Disease Control and Prevention (CDC) to improve the knowledge and skills of underserved ... been awarded a project by the CDC and allows AAFA to continue vital efforts ...
Breaking Medicine News(10 mins):
... and about 150 die every year. // ... Medicine in New York recently analyzed 31 allergy deaths. They ... teenagers or young adults. They were away from home when ... ,"We were surprised that so few people had gotten correct ...
... papers published in The Lancet on adolescent health, the current ... parents.// The infections of the earlier times like polio and ... drug abuse etc. The only silver lining to this issue ... ,Obesity in adolescents has increased fourfold between 1970 and ...
... the heart disease medicine of Sanofi-Aventis will be made indigenously ... Tuesday.// ,As per the offer made by Sanofa-Aventis, ... imitated version of the drug. The statement released by the ... will benefit the poorer Thai patients. According to a health ...
... be the latest trend which is making waves in the ... develop their skills to make sure the evaluation of the ... ,More than 170 physician performance measures have been ... Physician Consortium for Performance Improvement organized by the American Medical ...
... has asked the aerated drink manufacturers Pepsico and Coca Cola ... The Ganguly report had deduced that pesticide residues were found ... should be furnished within six weeks. ,Centre ... public interest litigation which stated that that the cola drinks ...
... computed tomography (CT) screening plays a vital role in ... screening determines how early the cancer is diagnosed. This ... treatment which can be curative,” said NY-ELCAP principal investigator ... Weill Cornell Medical College and chief of the divisions ...
Cached Medicine News:
(Date:10/9/2015)... , Oct. 9, 2015  Impax Laboratories, Inc. ... will release its third quarter 2015 financial results on ... the U.S. financial markets. The Company will host a ... at 8:30 a.m., Eastern Time on November 9, 2015.  ... . --> The financial results and live ...
(Date:10/9/2015)... 9, 2015 Eli Lilly and Company (NYSE: ... and approximately 50 new jobs to its research and development ... New York, New York . ... space will include a translational immuno-oncology hub and a Lilly ... collaborative access to cutting-edge drug discovery capabilities, including chemistry and ...
(Date:10/9/2015)...   --> --> Phase ... San Diego, California , by Dr. Tom Lyon , ... Center, on 9 th October 2015 at 8:30a.m. PDT. ... Tom Lyon , Director of Orthopaedics and Chief of Orthopaedic Trauma, ... 8:30a.m. PDT. --> Kuros Biosurgery AG, a biotechnology company ...
Breaking Medicine Technology:
... Talecris Biotherapeutics (Nasdaq: TLCR ) today ... Administration for PROLASTIN®-C (Alpha1-Proteinase Inhibitor [Human]), a more ... manufacturing technology. , Like PROLASTIN, the market leader ... the treatment of alpha1-antitrypsin (AAT) deficiency, a genetic ...
... BRIDGEWATER, N.J., Oct. 16 Sanofi-aventis U.S. announced that ... marketing approval for Elitek® (rasburicase) to be used for ... in adult patients with leukemia, lymphoma, and solid tumor ... in tumor lysis syndrome (TLS) and subsequent elevations of ...
Cached Medicine Technology:
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: