Cimzia® Approved In United States For Crohn's Disease

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Main Category: Crohn's
Also Included In: Clinical Trials / Drug Trials;  Arthritis / Rheumatology;  GastroIntestinal / Gastroenterology
Article Date: 23 Apr 2008 - 10:00 PDT

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According to a press release from UCB on April 22, 2008, a new pegylated anti-TNFα, will be made available in the United States under the name Cimzia® in the next few days. This will be a new, promising option for patients suffering from moderate to severe Crohn's Disease.

Crohn's Disease (CD) is a gastrointestinal disorder which is indicated by chronic inflammation of the wall of the digestive tract, usually in the ileum or large intestines. It usually affects young people, between the ages of 15 and 35. Approximately half a million people have the disease in Europe and the United States each. The disease involves constant cycles of flare-ups and remission throughout the life of the patient, and without proper treatment, must be addressed surgically. It is considered an inflammatory bowel disease (IBD), similar to ulcerative colitis.

Excess TNF-α production has been associated with a wide variety of diseases, and in recent research, TNF-α has become a central target for basic research and clinical investigation regarding pathological inflammation. Cimzia® (certolizumab pegol) is the first and only PEGylated anti-TNF-α (anti-tumor necrosis factor-α). The drug itself shows affinity for the human tumor necrosis factor-α (TNF-α), a cytokine that helps trigger many physiological responses including the immune reaction. This attraction allows the drug to neutralize TNF-α's potential pathophysiological effects.

In particular, Cimzia® has been studied for more than a decade in several clinical settings, including treatments for rheumatoid arthritis and CD. After initial dosing, administration of the drug occurs subcutaneously every four weeks. It is indicated for reducing the symptoms and signs of Crohn's disease and for maintaining clinical response in adult patients with moderate to severe symptoms who do not react adequately to conventional therapy.

Roch Doliveux, Chief Executive Officer of UCB Group expressed his optimism about the potential effects of the release of this drug. "The approval of Cimzia® in the United States is a significant milestone for both UCB and our Cimzia® team, but especially for people suffering from Crohn's disease," He said. "Cimzia® is a UCB biological innovation that will provide a monthly treatment option for patients suffering from Crohn's disease. Cimzia® will be available to doctors and Crohn's patients in the United States, which represents 70% of the world Crohn's anti-TNF market, within the next 48 hours."

Cimzia®'s approval was established based on safety and efficacy data from clinical trials performed in more than 1,500 patients with Crohn's disease. Each study showed statistically significant proportions of achieved and sustained clinical responses in moderate to severe CD patients for up to six months in comparison with a placebo. Additionally, patients who were in remission after initial dosing, for the most part, remained in remission without the need for escalation of the dose. The company points out many other advantages of Cimzia® for sufferers of moderate to severe CD, including its relatively infrequent administration, which is convenient for patients.

It also reports several side effects. The most commonly reported adverse events in the studies were upper respiratory tract infections, such as colds and flus, urinary tract infections, and joint pain. As with other anti-TNFα agents, there are also some serious but infrequent infections and malignancies reported. However, it has a low incidence of injection site reaction or pain in clinical trials.

Stephen Hanauer, M.D., Professor of Medicine and Clinical Pharmacology at the University of Chicago made a statement in which he endorses the new drug's results. "The clinical trials program has shown Cimzia® to be an effective subcutaneously- administered treatment, with a low rate of injection site reactions." He continues: "The approval of Cimzia® provides a new option for people with Crohn's disease to achieve relief from this debilitating condition with a convenient, stable administration once every four weeks."

About UCB
UCB (Brussels, Belgium) (www.ucb-group.com) is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialization of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology. UCB focuses on securing a leading position in severe disease categories. Employing around 12 000 people in over 40 countries, UCB achieved revenue of 3.6 billion euro in 2007. UCB S.A. is listed on Euronext Brussels.

Written by Anna Sophia McKenney


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