"Abbott announced today that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), granted a positive opinion recommending approval of HUMIRA(R) (adalimumab) for the treatment of severe Crohn's disease. HUMIRA will be the first self-administered biologic for the treatment of Crohn's disease. This is an important milestone for Abbott, as Crohn's disease will be the fourth approved indication for HUMIRA."

" Crohn's disease is a serious, chronic, inflammatory disease of the gastrointestinal (GI) tract that affects more than 1 million people in Europe and North America. There is no medical or surgical cure for Crohn's disease and there are few treatment options for patients suffering with this chronic condition. Crohn's affects people of all ages but it is primarily a disease of adolescents and young adults, with onset typically between the ages of 15 and 40."

" "HUMIRA will fill an important unmet need in Crohn's, a condition where we've had few effective treatment options, by offering sustained remission from disease and improved quality of life," said Jean-Frederic Colombel, M.D., professor of Gastroenterology, Hopital Huriez, France. "HUMIRA has been shown to be effective even in patients who have failed other therapies.""

" The European Commission is expected to issue a decision granting the marketing authorization for HUMIRA as a treatment of Crohn's disease in the European Union within the next 60 days. In Feb. 2007, HUMIRA was approved under priority review by the U.S. Food and Drug Administration for the treatment of moderately to severely active Crohn's disease."

" "The expected European approval of HUMIRA for the treatment of Crohn's disease represents a much anticipated option for physicians and patients," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development at Abbott. "HUMIRA offers patients sustained response and convenience as the only self-injectable biologic therapy.""

" The positive opinion is based on results of three randomized, double-blind, placebo-controlled, multi-center trials of HUMIRA. Clinical remission was measured by a Crohn.s Disease Activity Index (CDAI) score of less than 150. CDAI is a weighted composite score of eight clinical factors that evaluate patient wellness, including daily number of liquid or very soft stools, severity of abdominal pain, levels of general well being and other measures."

" -- CLASSIC I (Clinical assessment of Adalimumab Safety and efficacy Studied as an Induction therapy in Crohn's disease) was a study of 299 patients with moderate to severe Crohn's disease who were new to anti-TNF (tumor necrosis factor) therapy. Results showed that treatment with HUMIRA resulted in a greater percentage of patients achieving clinical remission at four weeks compared to placebo."

" -- CHARM (Crohn.s trial of the fully Human antibody Adalimumab for Remission Maintenance) was a 56-week trial that enrolled 854 patients with moderate to severely active Crohn's disease. The 499 patients who demonstrated clinical response (CDAI decrease of greater than or equal to 70 points from baseline) to HUMIRA during a four-week, open-label induction phase were randomized to receive either HUMIRA or placebo. A greater percentage of those who continued on HUMIRA maintained clinical remission through one year compared to placebo."

" -- GAIN (Gauging Adalimumab effectiveness in Infliximab Non-Responders) evaluated the efficacy of HUMIRA in 325 patients with moderate to severely active Crohn's disease who had previously lost response or were unable to tolerate infliximab. HUMIRA induced significantly higher rates of clinical remission compared to placebo."

" The safety profile of HUMIRA in the Crohn's clinical trials was similar to that seen in HUMIRA clinical trials for rheumatoid arthritis (RA). Adverse events reported by >5 percent of HUMIRA treated patients with a greater incidence than patients taking placebo include injection site irritation, injection site pain, injection site reaction, nausea, joint pain, inflammation of the nose and pharynx, abdominal pain, and headache."

" Crohn's disease is typically diagnosed before age 40. It can have a devastating impact on the lifestyles of patients, many of whom are young and active. Common symptoms of the disease include chronic diarrhea, cramping, abdominal pain, weight loss, fever, and in some cases, rectal bleeding. Over the course of their disease, at least 75 percent of patients with Crohn's will undergo surgery at least once for complications or disease resistant to treatment. Of those who undergo surgery to remove a portion of their intestines (resection), half will experience a relapse within five years."

" 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 RA 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."

" TNF antagonists, including HUMIRA, have been associated in rare cases with demyelinating disease and serious allergic reactions.
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