Cimzia® Approved In United States For Crohn's Disease

According to a press release from UCB on April 22, 2008, a new
pegylated
anti-TNF?±, 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-?± production has been associated with a wide variety of
diseases, and in recent research, TNF-?± 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-?± (anti-tumor necrosis
factor-?±). The drug itself shows affinity for the human tumor
necrosis factor-?± (TNF-?±), a cytokine that helps trigger many
physiological responses including the immune reaction. This attraction
allows the drug to neutralize TNF-?±'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-TNF?± 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) (ucb-group)
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



View drug information on Cimzia.