http://www.medicalnewstoday.com/articles/105112.php
Cimzia(R) Approved In United States For Crohn's Disease
Article Date: 23 Apr 2008 - 10:00 PDT
According to a press release from UCB on April 22, 2008, a new
pegylated anti-TNF=E1, will be made available in the United States under
the name Cimzia(R) in the next few days. This will be a new, promising
option for patients suffering from moderate to severe Crohn's Disease.
=2E..
In particular, Cimzia(R) 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.
=2E..
Cimzia(R)'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
pro****tions 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(R) for sufferers of moderate to severe CD, including its
relatively infrequent administration, which is convenient for
patients.
It also re****ts several side effects. The most commonly re****ted
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=E1 agents, there are also some serious but
infrequent infections and malignancies re****ted. However, it has a low
incidence of injection site reaction or pain in clinical trials.
=2E..
--
Luke
|
