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News Release - November 16, 2007
Abbott's HUMIRA(R) Receives Positive Opinion From EMEA for Treatment of Moderate to Severe Plaque PsoriasisABBOTT PARK, Ill., Nov. 16 (HSMN NewsFeed) -- The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), granted Abbott (NYSE: ABT ) a positive opinion recommending approval of HUMIRA® (adalimumab) for the treatment of moderate to severe plaque psoriasis. Psoriasis will be the fifth disease indication for HUMIRA.
Psoriasis is a non-contagious, chronic autoimmune disease that causes the body to attack itself. The most obvious physical symptom of the condition is raised, inflamed, scaly, red skin lesions known as plaques, which may crack and bleed. But psoriasis is more than painful skin lesions; data also suggest a correlation between psoriasis and other conditions, including psoriatic arthritis. In addition, psoriasis can seriously affect many aspects of a person's life, from professional and social activities to personal relationships.
"The scales and plaques of psoriasis can cause both physical and emotional distress, making reliable new treatment options essential," said Professor Jean-Hilaire Saurat, M.D., chairman, department of dermatology, University of Geneva, Switzerland. "With almost three quarters of patients in clinical trials achieving 75 percent clearance at sixteen weeks, and almost 20 percent achieving complete clearance, HUMIRA shows tremendous promise for physicians and people living with this condition."
Abbott announced it was seeking E.U. and U.S. regulatory approval for HUMIRA in psoriasis on April 2, 2007. The European Commission is expected to issue a decision granting the marketing authorization for HUMIRA as a treatment for psoriasis in the European Union within the next 60 days. Abbott is awaiting U.S. Food and Drug Administration approval for this indication.
"The skin clearance we have seen in HUMIRA psoriasis clinical trials, combined with ten years of clinical experience across indications and the convenience of self-injection, make HUMIRA a much anticipated treatment option for this condition," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development at Abbott.
About HUMIRA Psoriasis Clinical Trials
The opinion is primarily based on the results of two randomized, controlled, multi-center clinical trials in adult patients: REVEAL and CHAMPION. In both trials, the signs and symptoms of psoriasis were measured and evaluated using the Psoriasis Area and Severity Index (PASI) among other measures. CHAMPION was the first head-to-head study comparing a biologic medication to methotrexate, the standard systemic treatment for psoriasis.
-- 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 and symptoms of their disease at 16 weeks when treated with HUMIRA. Specifically, almost three out of four patients (71 percent) receiving HUMIRA achieved PASI 75 (75 percent or better improvement in PASI), compared to 6.5 percent of patients receiving placebo.
One in five patients (20 percent) receiving HUMIRA achieved PASI 100 (complete clearance), compared to 1 percent of patients receiving placebo. For patients who maintained a PASI 75 response after eight months of continuous HUMIRA therapy, patients were either continued on HUMIRA or administered placebo for the remainder of the study. Significantly fewer patients (5 percent) on HUMIRA lost response (<50 percent improvement in PASI response relative to baseline, with a minimum six point increase in PASI score compared to week 33) compared to patients on placebo (28 percent).
-- In CHAMPION, a pivotal 16-week study evaluating 271 psoriasis patients from eight European countries and Canada, HUMIRA-treated patients experienced a significant reduction in the signs and symptoms of their disease compared with methotrexate or placebo-treated patients, with more than twice the percentage (80 percent) of patients treated with HUMIRA achieving a PASI 75 response compared to patients treated with methotrexate (36 percent), a standard systemic treatment for psoriasis, and more than four times the percentage of patients treated with placebo (19 percent).
Nearly 17 percent of patients treated with HUMIRA achieved a PASI 100 response at week 16, compared to 7 percent of patients receiving methotrexate and 2 percent of patients receiving placebo. In addition, a mean percentage PASI improvement of 57 percent was achieved at week four in patients receiving HUMIRA, compared to baseline.
The most commonly reported adverse events in HUMIRA psoriasis trials were nasopharyngitis (inflammation of the nose and pharynx), upper respiratory tract infection and headache.
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 and toenails.
While psoriasis can occur in people of all ages, it typically appears in patients between the ages of 15 and 25. Psoriasis affects an estimated 125 million people worldwide, with approximately 25 percent of patients experiencing moderate to severe disease. The severity of the disease varies from person to person. Psoriasis can be a very isolating disease and people with psoriasis may suffer from poor self-image and even depression.
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 combination of HUMIRA and anakinra 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 (reported by 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) and Crohn.s disease in the United States and Europe. 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. To date, HUMIRA has been approved in 73 countries and more than 190,000 people worldwide are currently being treated with HUMIRA.
In May 2007, Abbott announced it had submitted E.U. and U.S. regulatory applications for HUMIRA to treat juvenile rheumatoid arthritis, also known as juvenile idiopathic arthritis. Clinical trials are also under way evaluating the potential of HUMIRA in ulcerative colitis.
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. In February 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 and in reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
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.
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. In June 2007, HUMIRA was approved in Europe for reducing the signs and symptoms and inducing and maintaining clinical remission in adults with severe active Crohn's disease, 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.
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.
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