Healthcare Industry News:  Ampion 

Biopharmaceuticals Dermatology FDA

 News Release - April 2, 2007

Abbott Seeks U.S. and E.U. Regulatory Approval for HUMIRA(R) (Adalimumab) in Psoriasis

Two Clinical Trials Demonstrate Promising Results in Psoriasis, the Fifth Autoimmune Disease Submission for HUMIRA

ABBOTT PARK, Ill., April 2 (HSMN NewsFeed) -- Abbott announced it has simultaneously submitted a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMEA) seeking approval to market HUMIRA® (adalimumab) as a treatment for moderate to severe chronic plaque psoriasis. Psoriasis affects 125 million people worldwide and is the fifth autoimmune disease targeted for HUMIRA therapy in both the United States and Europe.

Psoriasis is a non-contagious, chronic autoimmune disease that causes the body to attack itself and create raised, inflamed, scaly, red skin lesions known as plaques, which may crack and bleed. Psoriasis is more than skin lesions; it is painful and can impact many aspects of a person's life from professional and social activities to personal relationships. People with psoriasis may also suffer from poor self-image and social isolation.

The global submissions are based on the results of two double-blind, placebo-controlled trials of HUMIRA -- REVEAL and CHAmpion. In both trials, reduction in disease activity was determined by the Psoriasis Area and Severity Index (PASI) score, which measures the extent and severity of psoriasis.

"With the global submissions for HUMIRA in psoriasis, patients are closer to gaining a biologic treatment option that may provide clearance from painful and disfiguring skin lesions," said Alan Menter, M.D., chairman of the Division of Dermatology at Baylor University Medical Center, Dallas. "We expect that patients living with psoriasis, their families and their health care providers will welcome the results from HUMIRA clinical trials and the convenience of a self-administered injection."

About HUMIRA Psoriasis Clinical Trials

* In REVEAL, a pivotal 52-week trial, the short-term and sustained clinical efficacy and safety of HUMIRA were evaluated in more than 1,200 patients from the United States and Canada with moderate to severe chronic plaque psoriasis. Patients experienced a significant reduction in the signs of their disease at 16 weeks when treated with HUMIRA; specifically, almost three out of four patients (71 percent) receiving HUMIRA achieved PASI 75 or better, compared to only 6.5 percent of patients receiving placebo. One in five (20 percent) patients receiving HUMIRA achieved PASI 100 (complete clearance), compared to less than 1 percent of patients receiving placebo.

* In CHAmpion, a 16-week study evaluating 271 psoriasis patients from eight European countries and Canada, twice the percentage (80 percent) of patients treated with HUMIRA achieved PASI 75 compared to patients treated with methotrexate (36 percent), a standard systemic treatment for psoriasis, and four times more than patients treated with placebo (19 percent). Nearly 17 percent of patients treated with HUMIRA achieved PASI 100 at week 16, compared to 7 percent of patients receiving methotrexate and 2 percent of patients receiving placebo. In addition, a mean PASI improvement of 57 percent was achieved at week four in patients receiving HUMIRA, compared to baseline.

"With almost 20 percent of patients achieving PASI 100, or complete clearance, in these two clinical trials, HUMIRA shows tremendous promise for physicians and people living with this condition, which has no cure," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development at Abbott.

The adverse events observed in REVEAL and CHAmpion were similar to those observed in previous HUMIRA studies. The most commonly reported adverse events in HUMIRA psoriasis trials were upper respiratory tract infection, nasopharyngitis (inflammation of the nose and pharynx) and headache.

HUMIRA has almost ten years of clinical experience. More than 180,000 patients worldwide are currently being treated with HUMIRA. HUMIRA is also approved to treat psoriatic arthritis, a form of arthritis that affects up to 30 percent of people with psoriasis.

More Information About Psoriasis

Psoriasis is a chronic autoimmune disease that speeds the growth cycle of skin cells and results in thick scaly areas of skin. The most common form of psoriasis appears as red, raised areas of skin covered with flaky white scales, which may itch or burn. Psoriasis most commonly appears on the scalp, knees, elbows, lower back, hands and feet, though it can develop anywhere on the skin. It may even occur in the fingernails, toenails and in the joints. While psoriasis can occur in people of all ages, it typically appears in patients between the ages of 15 and 35. The severity of the disease varies from person to person. Currently, there is no cure for psoriasis.

Important Safety Information

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

Serious infections, sepsis, tuberculosis (TB) and rare cases of opportunistic infections, including fatalities, have been reported with the use of TNF-blocking agents, including HUMIRA. Many of these serious infections have occurred in patients also taking other immunosuppressive agents that in addition to their underlying disease could predispose them to infections. Treatment with HUMIRA should not be initiated in patients with active infections. TNF-blocking agents, including HUMIRA, have been associated with reactivation of hepatitis B (HBV) in patients who are chronic carriers of this virus. Some cases have been fatal. Patients at risk for HBV infections should be evaluated for prior evidence of HBV infections before initiating HUMIRA. The combination of HUMIRA and anakinra is not recommended.

TNF-blocking agents, including HUMIRA, have been associated in rare cases with demyelinating disease and severe allergic reactions. Infrequent reports of serious blood disorders have been reported with TNF-blocking agents. More cases of malignancies have been observed among patients receiving TNF blockers, including HUMIRA, compared to control patients in clinical trials. These malignancies, other than lymphoma and non-melanoma skin cancer, were similar in type and number to what would be expected in the general population. There was an approximately four fold higher rate of lymphoma in combined controlled and uncontrolled open-label portions of HUMIRA clinical trials. The potential role of TNF-blocking therapy in the development of malignancies is not known.

Worsening congestive heart failure (CHF) has been observed with TNF- blocking agents, including HUMIRA, and new onset CHF has been reported with TNF-blocking agents. Treatment with HUMIRA may result in the formation of autoantibodies and rarely, in development of a lupus-like syndrome.

The most frequent adverse events seen in the placebo-controlled clinical trials in rheumatoid arthritis (HUMIRA vs. placebo) were injection site reactions (20 percent vs. 14 percent), upper respiratory infection (17 percent vs. 13 percent), injection site pain (12 percent vs. 12 percent), headache (12 percent vs. 8 percent), rash (12 percent vs. 6 percent) and sinusitis (11 percent vs. 9 percent). Discontinuations due to adverse events were 7 percent for HUMIRA and 4 percent for placebo. As with any treatment program, the benefits and risks of HUMIRA should be carefully considered before initiating therapy.

In HUMIRA clinical trials for ankylosing spondylitis, psoriatic arthritis and Crohn's disease, the safety profile for patients treated with HUMIRA was similar to the safety profile seen in patients with rheumatoid arthritis.

About HUMIRA

HUMIRA is the only fully human monoclonal antibody approved for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) in the United States and Europe. HUMIRA resembles antibodies normally found in the body. It works by blocking tumor necrosis factor alpha (TNF-.), a protein that when produced in excess, plays a central role in the inflammatory responses of many immune-mediated diseases. To date, HUMIRA has been approved in 67 countries and more than 180,000 people worldwide are currently being treated with HUMIRA.

Clinical trials are currently under way evaluating the potential of HUMIRA in other immune-mediated diseases. Abbott plans to begin trials of HUMIRA in children and adolescents with psoriasis later this year.

In the United States, HUMIRA is approved by the FDA for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of joint structural damage, and improving physical function in adult patients with moderately to severely active RA. 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 methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs). HUMIRA is also approved for reducing signs and symptoms in patients with active AS. On Feb. 27, 2007 HUMIRA was approved 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.

In Europe, HUMIRA, in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe, active RA in adult patients when the response to disease-modifying anti-rheumatic drugs (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.

Additionally, 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.

Abbott's Commitment to Immunology

Abbott is focused on the discovery and development of innovative treatments for immunologic diseases. The Abbott Bioresearch Center, founded in 1989 in Worcester, Mass., United States, is a world-class discovery and basic research facility committed to finding new treatments for autoimmune diseases.

More information about HUMIRA, including full prescribing information, is available on the Web site www.HUMIRA.com or in the United States by calling Abbott Medical Information at 1-800-633-9110.

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 65,000 people and markets its products in more than 130 countries.


Source: Abbott

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