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Biopharmaceuticals Gastroenterology FDA

 News Release - October 26, 2006

Abbott's HUMIRA(R) (Adalimumab) Granted FDA Priority Review for the Treatment of Moderately to Severely Active Crohn's Disease

Supporting Data Shows Potential to Benefit Patients Without an Effective Treatment Option

ABBOTT PARK, Ill., Oct. 26 (HSMN NewsFeed) -- Abbott announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for its recent supplemental Biologics License Application (sBLA) for HUMIRA® (adalimumab) as a treatment for moderately to severely active Crohn's disease. This Priority Review is based on findings released earlier this month from the GAIN study, Gauging Adalimumab Efficacy in Infliximab Non- Responders, which showed HUMIRA induced clinical remission at four weeks in patients with moderately to severely active Crohn's disease who lost response to, or were intolerant to, infliximab therapy.

Crohn's disease is a serious, chronic inflammatory disease of the gastrointestinal (GI) track that may affect more than one million people in North America and Europe. There is no medical or surgical cure for Crohn's disease and few options for patients suffering with this chronic condition.

The FDA granted Priority Review status to HUMIRA based on its potential to address an unmet medical need for Crohn's disease. Additional FDA attention and resources are directed to drugs with Priority Review status, but it does not alter the scientific/medical standard for approval or the quality of the evidence necessary. The goal for reviewing a drug with Priority Review status is six months versus a standard 10-month review.

Abbott announced the submission of a supplemental Biologics License Application (sBLA) with the FDA seeking approval to market HUMIRA as a treatment for moderate-to-severe Crohn's disease on September 7, 2006. The submission includes results from three randomized, double-blind, placebo- controlled trials of HUMIRA in Crohn's disease, including the GAIN, CLASSIC and CHARM trials.

"Patients who have failed infliximab have limited treatment options and this decision underscores the need for new therapies that address unmet medical needs," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. "We are pleased the FDA has granted Priority Review to HUMIRA for the treatment of Crohn's disease."

About GAIN

GAIN, a randomized, double-blind, placebo-controlled study, was designed to assess the efficacy and safety of HUMIRA in moderately to severely active Crohn's disease in patients who previously lost response to, or were intolerant to, infliximab therapy, a group currently without effective treatment options. Data from the study of 325 patients showed significantly higher rates of remission for patients receiving HUMIRA compared to those receiving placebo at week four, 21 percent versus 7 percent respectively (p less than or equal to 0.001).

Clinical remission was measured by a decrease in the Crohn's Disease Activity Index (CDAI). 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, level of general well-being and other measures.

The safety profile in the GAIN study was consistent with previous reports in Crohn's disease and rheumatoid arthritis studies of HUMIRA. The most frequently reported treatment emergent adverse events (greater than or equal to 5 percent) for patients in the HUMIRA arm included abdominal pain, joint pain, headache, and injection site irritation.

About Crohn's Disease

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 diarrhea, cramping, abdominal pain, weight loss, fever, and in some cases, rectal bleeding. Over the course of their disease, at least 50 percent of patients with Crohn's will undergo surgery at least once for complications or disease refractory to treatment, and up to 70 percent of those patients will require a second surgery.

Important Safety 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.

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 and psoriatic arthritis, 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 U.S. and Europe. HUMIRA resembles antibodies normally found in the body. It works by blocking tumor necrosis factor alpha (TNF-alpha), a protein that plays a central role in the inflammatory responses of autoimmune diseases. To date, HUMIRA has been approved in 67 countries and more than 160,000 people worldwide are currently being treated with HUMIRA. Clinical trials are currently under way evaluating the potential of HUMIRA in other autoimmune diseases.

In the U.S., HUMIRA is approved by the FDA for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. HUMIRA is also indicated for reducing the signs and symptoms of active arthritis in patients with PsA. 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 http://www.rxabbott.com 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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