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Biopharmaceuticals Gastroenterology FDA

 News Release - February 27, 2007

HUMIRA(R) (Adalimumab) Receives FDA Approval For Treatment of Crohn's Disease

HUMIRA is the First and Only Self-Administered Biologic Treatment for Moderate to Severe Crohn's Disease

ABBOTT PARK, Ill., Feb. 27 (HSMN NewsFeed) -- Abbott announced today it has received U.S. Food and Drug Administration (FDA) approval to market HUMIRA® (adalimumab) as a treatment 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 also indicated for reducing the signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab, the only other approved biologic for treatment of Crohn's disease.

Crohn's disease is a serious chronic, inflammatory disease of the gastrointestinal (GI) tract that affects more than one million people in North America and Europe. It affects people of all ages but it is primarily a disease of young adults, with onset typically before age 40. There is no medical or surgical cure for Crohn's disease and few options exist for patients suffering with this chronic condition. This approval establishes HUMIRA as the first and only self-administered biologic for the treatment of Crohn's disease. Crohn's disease is the fourth FDA approval in immune- mediated diseases for HUMIRA.

"For many people with Crohn's disease, the unpredictable nature of the disease can make day-to-day life more challenging because symptoms can flare without warning," said Richard J. Geswell, president of the Crohn's & Colitis Foundation of America (CCFA). "The approval of HUMIRA provides a new and effective treatment option to help patients take control of their disease and improve their quality of life."

Common symptoms of Crohn's disease include diarrhea, cramping, abdominal pain, weight loss, fever, and in some cases, rectal bleeding. Complications include intestinal obstruction, fistulas (ulcers that form tunnels to surrounding tissues), and malnutrition. Over the course of their disease, as many as 75 percent of patients with Crohn's disease will undergo surgery at least once for complications or disease resistant to treatment. Of those who undergo surgery to remove a portion of the intestines (resection), half will experience a relapse within five years.

"The HUMIRA approval gives patients access to a treatment that may significantly impact their symptoms and give them more freedom to engage in daily activities such as family outings, shopping and traveling," said Stephen Hanauer, M.D., professor of Medicine and Clinical Pharmacology at the University of Chicago.

"My Crohn's disease was overwhelming," said Debra Ann Weiss, a HUMIRA clinical trial patient. "Treatment with HUMIRA gave me relief from my symptoms, which meant that my Crohn's disease stopped running my life."

Abbott simultaneously submitted applications with the FDA and the European Medicines Agency (EMEA) seeking approval to market HUMIRA to treat Crohn's disease in September 2006. Approval to market HUMIRA as a treatment of Crohn's disease in the European Union is anticipated within the first half of 2007.

"The approval in Crohn's disease extends the reach of HUMIRA beyond rheumatology and dermatology to an underserved patient population in gastroenterology," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development at Abbott. "In addition to rapid and sustained response, HUMIRA offers patients with moderate to severe Crohn's disease the convenience of self-injection in the comfort of their home."

HUMIRA for Crohn's Disease

The approval was based on data from three pivotal trials of HUMIRA in more than 1,400 adult patients with moderately to severely active Crohn's disease. The CLASSIC I, CHARM and GAIN trials supporting the indication for Crohn's disease evaluated the efficacy and safety of HUMIRA in a diverse group of moderate to severe adult Crohn's disease patients, from those who were naive to anti-tumor necrosis factor alpha (TNF-alpha), therapy to patients who had previously lost response or were unable to tolerate infliximab, a biologic for treatment of Crohn's disease that is delivered by infusion.

In each trial, 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.

Key outcomes include:

-- The CLASSIC I induction trial evaluated the ability of HUMIRA to induce remission. Of 299 anti-TNF naive patients, 36 percent of patients receiving HUMIRA (160 mg at week zero followed by 80 mg at week two) achieved clinical remission at week four compared to 12 percent treated with placebo (p<0.001).

-- The CHARM trial studied the ability of HUMIRA to maintain clinical remission. CHARM was a 56-week trial that enrolled 854 patients with moderate to severe Crohn's disease. During a four-week open label induction phase, 58 percent of patients (499) demonstrated clinical response to HUMIRA (a CDAI decrease equal to or greater than 70 from baseline). These patients were randomized to receive either HUMIRA 40 mg every other week (eow), HUMIRA 40 mg weekly, or placebo. Of those who continued on HUMIRA 40 mg every other week, 40 percent were in clinical remission at week 26 (p<0.001) and 36 percent were in remission at week 56 (p<0.001), versus 17 percent and 12 percent of patients in the placebo group, respectively.

-- In GAIN, a four-week induction trial of 325 patients who lost response or were intolerant to infliximab, three times as many patients taking HUMIRA achieved clinical remission at week four versus placebo (21 percent versus 7 percent, p less than or equal to 0.001).

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 160 mg/80 mg treated patients during the CLASSIC I and GAIN induction trials with a greater incidence than patients taking placebo include injection site irritation (8 percent versus 6 percent), nausea (6 percent versus 4 percent), and joint pain (6 percent versus 3 percent). Adverse events reported by >5 percent of HUMIRA 40 mg eow treated patients during the CHARM maintenance trial with a greater incidence than patients taking placebo include nasopharyngitis (9 percent versus 7 percent), abdominal pain (7 percent versus 7 percent), headache (7 percent versus 6 percent), and nausea (7 percent versus 6 percent).

The recommended dosing of HUMIRA for Crohn's disease is an induction dose of 160 mg with an 80 mg dose at week two, followed by maintenance dose of 40 mg every other week beginning at week four. The initial dose may be given as four injections on one day, or divided over two days. This approval marks the first indication to launch with the HUMIRA Pen, which was approved by the FDA in June 2006. The TOUCH trial found patients preferred the HUMIRA Pen over the HUMIRA pre-filled syringe, and that it offered improved ease of use and less pain compared to the HUMIRA pre-filled syringe. HUMIRA is the first and only biologic treatment for Crohn's disease to offer adult patients, many who are young and active, the convenience of self-injection in the comfort of their own home.

Important Safety Information

Serious infections, sepsis, tuberculosis (TB) and 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. Infections have also been reported in patients receiving HUMIRA alone. 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 infection should be evaluated for prior evidence of HBV infection before initiating Humira. The combination of HUMIRA and anakinra is not recommended and patients using HUMIRA should not receive live vaccines.

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 3.5 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. 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.

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.


In addition to approval in the U.S. to treat Crohn's disease, 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 U.S. and Europe. HUMIRA resembles antibodies normally found in the body. It works by blocking 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 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.

In the U.S., HUMIRA is also 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 was also approved on July 28, 2006 for reducing signs and symptoms in patients with active AS.

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 or in the United States by calling Abbott Medical Information at 1-800-633-9110.

About Abbott

Abbott (NYSE: ABT ) 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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