The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), granted Abbott 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.
This post may contain sponsored links
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.
This post may contain sponsored links
Author:
Time:
Sunday, November 18th, 2007 at 10:39 pm
Category:
Comments:
You can leave a response, or trackback from your own site.
RSS:
You can follow any responses to this entry through the RSS 2.0 feed.
Navigation: