Abbott receives positive opinion from CHMP of the EMA about HUMIRA ® in ulcerative colitis

the positive opinion is based on two phase III clinical studies confirmatory data.

Abbott Park, ill., February 2012. Abbott has announced on Monday that the Committee for medicinal products for human use (CHMP) has issued a positive opinion about HUMIRA ® (adalimumab) in adults with active colitis ulcerative (CU) of moderate to severe that they have failed, cannot tolerate or have medical contraindications to conventional treatments. Based on the positive evaluation of the CHMP, a final decision by the European Commission is expected in the coming weeks. With the issuance of this final decision, HUMIRA will be the first and only biological treatment self-injectable available for patients with moderate to severe CU.

The CU is a chronic intestinal inflammatory disease that produces an inflammation of the colon and can cause life-threatening complications. Currently, only final cure is known for the CU is the surgical removal of the colon. It estimates that the CU affects up to 1.2 million people in the European Union and that approximately 25% of patients with UC will be submitted to some kind of surgery to treat the symptoms throughout their lives.

“A diagnosis of ulcerative colitis may be a tremendous blow: can alter the life of the patient and cause pain, bleeding, and hospitalization”, explained John Leonard, M.D., Senior Vice President of the Pharmaceuticals Research and Development of Abbott. “The positive assessment of today is a step forward to HUMIRA disposition of patients with CU in the European Union and underlines our long-term commitment to patients with inflammatory bowel disease.”

The positive opinion of HUMIRA for the indication in the CU is based on two phase III clinical trials that evaluated with HUMIRA clinical remission in adult patients with moderate to severe CU. HUMIRA is indicated for the treatment of moderate to severe active Ulcerative colitis in adult patients with an inadequate response to conventional treatment, such as corticosteroids and 6-Mercaptopurine (6-MP) or azathioprine (AZA), or they do not tolerate or have medical contraindications to these treatments.

About the CU

The CU is a chronic inflammatory bowel disease that causes inflammation of the rectum and colon, causing diarrhea, rectorragia and abdominal colic pain. Average, CU is diagnosed to people by the age of 30, although the disease can occur at any time. The symptoms of UC is usually intermittent, with periods varied clinical stability, dotted with episodic outbreaks of disease activity. Common symptoms include frequent and loose stools and rectorragia. Serious outbreaks of CU may require hospitalization and may be life-threatening. Treatment may include medication and surgery.


Globally, the indications and information on prescription vary; for further information about Humira, consult the technical specifications of the product on the website of the Spanish Agency of medicines and medical devices.

Important safety information

HUMIRA is an antagonist of the TNF that affects the immune system and can decrease your ability to fight infections.

People treated with HUMIRA have one higher risk of developing severe infections that can lead to hospitalization or death. Reported severe infections include tuberculosis (TB) and infections by viruses, fungi or bacteria that have spread around the body. Before taking HUMIRA should do tests of TB to people and control the signs and symptoms of TB during treatment. The people at risk of TB can be treated with anti-TB. Treatment with HUMIRA should fail to launch in a person with an active infection, unless authorized by a physician. HUMIRA should be suspended if a person develops a serious infection.

In people who take antagonists of TNF as HUMIRA, the possibility of developing Lymphoma or other cancers may increase. Some people have developed a rare type of cancer called Lymphoma, T-cell hepatoesplénico. This type of cancer often ends in death. Other possible serious side effects of HUMIRA include hepatitis B virus in carriers of the virus, allergic reactions, problems of the nervous system, blood problems, certain immune reactions, as a syndrome similar to lupus, liver problems or appearance or worsening of psoriasis or heart failure. Use HUMIRA with anakinra or abatacept is not recommended. Persons using HUMIRA should not receive vaccines with live germs.

Common side effects of HUMIRA include reactions at the point of injection (redness, rash, swelling, itching, or bruising), infections of respiratory tract superiors (such as sinus infections), headaches, rash and nausea.

As in any therapeutic program, before initiating the treatment should be considered carefully the risks and benefits of HUMIRA.

About Abbott

Abbott is a biomedical company dedicated to the discovery, development, manufacture and marketing of pharmaceuticals, nutritional, health and diagnosis. The company employs 91,000 people worldwide and sells its products in more than 130 countries.

Abbott is certified as Top Employers Spain 2011 by CRF Institute, and as the best company to work in the health sector and the second in the general ranking of sectors according to Best 2009″ Spain 2010. Abbott has over 1,500 employees and 61 years of history in our country. The company’s activity is oriented to meet the needs of patients with chronic diseases and high-impact clinical, economic, social, and emotional. Abbott has presence in all areas of the Spanish healthcare industry (including r & d and manufacturing at its centres in Madrid, Granada and Alcobendas). Its products cover all phases of the process of the disease (prevention, diagnosis, treatment and healing) and are present at every moment of the life cycle: newborn, childhood, adolescence, maturity and old age.