UCB's CIMZIA(R) (certolizumab pegol) Approved by the U.S. FDA for Adult
Patients Suffering From Moderate to Severe Rheumatoid Arthritis
- Available this week, Cimzia(R) (certolizumab pegol), the only pegylated
anti-TNF, offers a new treatment option for U.S. adult patients suffering from
moderately to severely active rheumatoid arthritis
- Patients treated with Cimzia(R), together with methotrexate, experienced
rapid and significant improvements in signs and symptoms, physical function
and pain as early as week one, and sustained at week 24 and for up to one year
- Patients treated with Cimzia(R) as a monotherapy experienced significant
improvements in signs and symptoms, physical function and pain
- Cimzia(R) is available in an exclusively designed, patient-friendly,
prefilled syringe resulting from the UCB partnership with OXO(R). The new
syringe carries the Arthritis Foundation(TM) Ease-of-Use Commendation
- Cimzia(R) offers U.S. adult patients flexible maintenance dosing, either at
two or four weeks after initial doses, and can be used together with
methotrexate or as a monotherapy
ATLANTA, May 13 /PRNewswire/ -- regulated information -- UCB announced today
that the U.S. Food and Drug Administration (FDA) approved Cimzia(R), the only
PEGylated anti-TNF (Tumor Necrosis Factor), for the treatment of adult
patients with moderately to severely active rheumatoid arthritis (RA).
Cimzia(R) can be dosed at 400 mg initially and at weeks two and four, followed
by 200 mg every other week; for maintenance dosing, 400 mg every four weeks
can be considered.
In clinical trials with Cimzia(R), together with methotrexate (MTX), patients
experienced a significant reduction in the signs and symptoms of RA at week 24
with some showing clinical responses within one to two weeks, compared with
MTX alone. Additionally, radiographic data showed Cimzia(R), together with
MTX, inhibited progression of joint damage, with a significantly smaller
change from baseline in modified Total Sharp Score (TSS) at 24 and 52 weeks of
treatment, compared with MTX alone (p<0.001).
"The approval of Cimzia(R) for moderate to severe rheumatoid arthritis in the
U.S. is a major milestone for UCB, and most importantly, for people seeking a
new treatment option to manage this debilitating condition," said Roch
Doliveux, Chief Executive Officer of UCB. "UCB is committed to developing new
therapies, such as Cimzia(R), to help meet the needs of patients living with
rheumatoid arthritis and other immune diseases. I am also proud of our
partnership with OXO(R) and of the fact that RA patients were directly
involved in the design and development of our new prefilled syringe, which is
designed to make self-administration easy for people living with rheumatoid
arthritis."
The new prefilled Cimzia(R) syringe is now also available for subcutaneous
self-administration to U.S. patients with moderate to severe Crohn's disease
who have had an inadequate response to conventional therapy.
The FDA approval is based on UCB's comprehensive clinical program, including
data from four multi-center placebo-controlled phase III trials, involving
more than 2 300 patients with RA and over 4 000 patient-years experience.
Cimzia(R) has been studied at dosing intervals of two or four weeks, and
administered together with MTX or as monotherapy.
In the pivotal clinical trials, reported serious adverse reactions were
infections including tuberculosis and malignancies including lymphoma. The
most commonly occurring adverse events were upper respiratory tract
infections, rash and urinary tract infections. A pooled analysis of the safety
data show there was a low incidence of injection site pain (<2%) and a low
level of discontinuations due to adverse events (5%).
"People with RA have pain and swelling of joints with stiffness and fatigue
which makes it difficult for them to perform many activities of daily living,
sometimes making it a struggle to even get out of bed," said Roy Fleischmann,
MD, Clinical Professor in the Department of Internal Medicine at the
University of Texas Southwestern Medical Center in Dallas. "With the approval
of Cimzia(R), I now have another alternative to offer my patients in an
easy-to-use treatment that improves quality of life and inhibits structural
damage."
It is estimated that 5 million people suffer from RA globally. In the United
States alone, an estimated 1.3 million people have the disease. Prevalence is
not split evenly between genders, since women are three times more likely to
be affected than men. Although RA can affect people of all ages, the onset of
the disease usually occurs between 35-55 years of age.
Notes to the editor:
About CIMZIA(R)
Cimzia(R) is the only PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia(R)
has a high affinity for human TNF-alpha, selectively neutralizing the
pathophysiological effects of TNF-alpha. Over the past decade, TNF-alpha has
emerged as a major target of basic research and clinical investigation. This
cytokine plays a key role in mediating pathological inflammation, and excess
TNF-alpha production has been directly implicated in a wide variety of
diseases. The U.S. Food and Drug Administration (FDA) has approved Cimzia(R)
for reducing signs and symptoms of Crohn's disease and maintaining clinical
response in adult patients with moderate to severe active disease who have had
an inadequate response to conventional therapy and for the treatment of adults
with moderate to severely active rheumatoid arthritis. Cimzia(R) was approved
in Switzerland for induction of a clinical response and for the maintenance of
a clinical response and remission in patients with active Crohn's disease who
have not responded adequately to conventional treatment in September 2007. UCB
is also developing Cimzia(R) in other autoimmune disease indications.
Cimzia(R) is a registered trademark of UCB PHARMA S.A.
OXO(R) and GOOD GRIPS(R) are trademarks of Helen of Troy Limited (NASDAQ HELE)
and are used under license
IMPORTANT SAFETY INFORMATION
Patients treated with CIMZIA are at an increased risk for developing serious
infections that may lead to hospitalization or death. Most patients who
developed these infections were taking concomitant immunosuppressants such as
methotrexate or corticosteroids. CIMZIA should be discontinued if a patient
develops a serious infection or sepsis. Reported infections include:
-- Active tuberculosis, including reactivation of latent tuberculosis.
Patients with tuberculosis have frequently presented with disseminated
or extrapulmonary disease. Patients should be tested for latent
tuberculosis before CIMZIA use and during therapy. Treatment for
latent
infection should be initiated prior to CIMZIA use.
-- Invasive fungal infections, including histoplasmosis ,
coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and
pneumocystosis. Patients with histoplasmosis or other invasive fungal
infections may present with disseminated, rather than localized
disease.
Antigen and antibody testing for histoplasmosis may be negative in
some
patients with active infection. Empiric anti-fungal therapy should be
considered in patients at risk for invasive fungal infections who
develop severe systemic illness .
-- Bacterial, viral and other infections due to opportunistic pathogens.
The risks and benefits of treatment with CIMZIA should be carefully considered
prior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms
of infection during and after treatment with CIMZIA, including the possible
development of tuberculosis in patients who tested negative for latent
tuberculosis infection prior to initiating therapy.
Serious and sometimes fatal infection due to bacterial, mycobacterial,
invasive fungal, viral or other opportunistic pathogens has been reported in
patients receiving TNF-blocking agents. Among opportunistic infections,
tuberculosis, histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis,
listeriosis, and pneumocystosis were the most common. Treatment with CIMZIA
should not be initiated in patients with an active infection, including
clinically important localized infections. The risks and benefits of
treatment should be considered prior to initiating therapy in patients with
chronic or recurrent infection, who have been exposed to tuberculosis, who
have resided or traveled in areas of endemic tuberculosis or endemic mycoses,
such as histoplasmosis, coccidioidomycosis, or blastomycosis, or with
underlying conditions that may predispose them to infection.
Patients should be evaluated for tuberculosis risk factors and tested for
latent infection prior to initiating CIMZIA and periodically during therapy.
Patients should be closely monitored for the development of signs and symptoms
of infections during and after treatment with CIMZIA, including development of
tuberculosis in patients who tested negative for latent tuberculosis infection
prior to initiating therapy. CIMZIA should be discontinued if a patient
develops a serious infection or sepsis. Patients who develop a new infection
during treatment with CIMZIA should be closely monitored, undergo a prompt and
complete diagnostic workup appropriate for immunocompromised patients, and
appropriate antimicrobial therapy should be initiated. Appropriate empiric
antifungal therapy should also be considered while a diagnostic workup is
performed for patients who develop a serious systemic illness and reside or
travel in regions where mycoses are endemic.
During controlled and open-labeled portions of CIMZIA studies of Crohn's
disease and other diseases, malignancies (excluding non-melanoma skin cancer)
were observed at a rate (95% confidence interval) of 0.5 (0.4, 0.7 ) per 100
patient-years among 4,650 CIMZIA-treated patients versus a rate of 0.6 (0.1,
1.7) per 100 patient-years among 1,319 placebo-treated patients. The size of
the control group and limited duration of the controlled portions of the
studies preclude the ability to draw firm conclusions. In studies of CIMZIA
for Crohn's disease and other investigational uses, there was one case of
lymphoma among 2,657 CIMZIA-treated patients and one case of Hodgkin lymphoma
among 1,319 placebo-treated patients. In CIMZIA RA clinical trials
(placebo-controlled and open label) a total of three cases of lymphoma were
observed among 2,367 patients. This is approximately 2-fold higher than
expected in the general population. Patients with RA, particularly those with
highly active disease, are at a higher risk for the development of lymphoma.
The potential role of TNF blocker therapy in the development of malignancies
is not known.
Cases of worsening congestive heart failure (CHF) and new onset CHF have been
reported with TNF blockers. CIMZIA has not been formally studied in patients
with CHF. Exercise caution when using CIMZIA in patients who have heart
failure and monitor them carefully.
Symptoms compatible with hypersensitivity reactions, including angioedema,
dyspnea, hypotension, rash, serum sickness, and urticaria, have been reported
rarely following CIMZIA administration. If such reactions occur, discontinue
further administration of CIMZIA and institute appropriate therapy.
Use of TNF blockers, including CIMZIA, may increase the risk of reactivation
of hepatitis B virus (HBV) in patients who are chronic carriers of this virus.
Some cases have been fatal. Evaluate patients at risk for HBV infection for
prior evidence of HBV infection before initiating CIMZIA therapy. Exercise
caution in prescribing CIMZIA for patients identified as carriers of HBV.
Patients who are carriers of HBV and require treatment with CIMZIA should be
closely monitored for clinical and laboratory signs of active HBV infection
throughout therapy and for several months following termination of therapy. In
patients who develop HBV reactivation, discontinue CIMZIA and initiate
effective anti-viral therapy with appropriate supportive treatment.
Use of TNF blockers, including CIMZIA, has been associated with rare cases of
new onset or exacerbation of clinical symptoms and/or radiographic evidence of
demyelinating disease. Rare cases of neurological disorders, including seizure
disorder, optic neuritis, and peripheral neuropathy have been reported in
patients treated with CIMZIA; the causal relationship to CIMZIA remains
unclear. Exercise caution in considering the use of CIMZIA in patients with
these disorders.
Rare reports of pancytopenia, including aplastic anemia, have been reported
with TNF blockers. Medically significant cytopenia (e.g., leukopenia,
pancytopenia, thrombocytopenia) has been infrequently reported with CIMZIA.
The causal relationship of these events to CIMZIA remains unclear. Advise all
patients to seek immediate medical attention if they develop signs and
symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever,
bruising, bleeding, pallor) while on CIMZIA. Consider discontinuation of
CIMZIA therapy in patients with confirmed significant hematologic
abnormalities.
An increased risk of serious infections has been seen in clinical trials of
other TNF blocking agents used in combination with anakinra or abatacept.
Formal drug interaction studies have not been performed with rituximab or
natalizumab; however because of the nature of the adverse events seen with
these combinations with TNF blocker therapy, similar toxicities may also
result from the use of CIMZIA in these combinations. Therefore, the
combination of CIMZIA with anakinra, abatacept, rituximab, or natalizumab is
not recommended.
Treatment with CIMZIA may result in the formation of autoantibodies and,
rarely, in the development of a lupus-like syndrome. Discontinue treatment if
symptoms of lupus-like syndrome develop.
Do not administer live vaccines or attenuated vaccines concurrently with
CIMZIA.
Interference with certain coagulation assays has been detected in patients
treated with CIMZIA. There is no evidence that CIMZIA therapy has an effect on
in vivo coagulation. CIMZIA may cause erroneously elevated aPTT assay results
in patients without coagulation abnormalities.
In controlled Crohn's clinical trials, the most common adverse events that
occurred in greater than or equal to 5% of CIMZIA patients (n=620) and more
frequently than with placebo (n=614) were upper respiratory infection (20%
CIMZIA, 13% placebo), urinary tract infection (7% CIMZIA, 6% placebo), and
arthralgia (6% CIMZIA, 4% placebo). The proportion of patients who
discontinued treatment due to adverse reactions in the controlled clinical
studies was 8% for CIMZIA and 7% for placebo.
In controlled RA clinical trials, the most common adverse events that occurred
in greater than or equal to 3% of patients taking CIMZIA 200 mg every other
week with concomitant methotrexate (n=640) and more frequently than with
placebo with concomitant methotrexate (n=324) were upper respiratory tract
infection (6% CIMZIA, 2% placebo), headache (5% CIMZIA, 4% placebo),
hypertension (5% CIMZIA, 2% placebo), nasopharyngitis (5% CIMZIA, 1% placebo),
back pain (4% CIMZIA, 1% placebo), pyrexia (3% CIMZIA, 2% placebo),
pharyngitis (3% CIMZIA, 1% placebo), rash (3% CIMZIA, 1% placebo), acute
bronchitis (3% CIMZIA,1% placebo), fatigue (3% CIMZIA, 1% placebo).
Hypertensive adverse reactions were observed more frequently in patients
receiving CIMZIA than in controls. These adverse reactions occurred more
frequently among patients with a baseline history of hypertension and among
patients receiving concomitant corticosteroids and non-steroidal
anti-inflammatory drugs. Patients receiving CIMZIA 400mg as monotherapy every
4 weeks in RA controlled clinical trials had similar adverse reactions to
those patients receiving CIMZIA 200mg every other week. The proportion of
patients who discontinued treatment due to adverse reactions in the controlled
clinical studies was 5% for CIMZIA and 2.5% for placebo. Please see full
prescribing information on www.Cimzia.com.
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a biopharmaceutical company dedicated
to the research, development and commercialization of innovative medicines
with a focus on the fields of central nervous system and immunology disorders.
Employing approximately 10 000 people in over 40 countries, UCB generated
revenue of EUR 3.6 billion in 2008. UCB is listed on Euronext Brussels
(symbol: UCB).
Forward-looking statements
This press release contains forward-looking statements based on current plans,
estimates and beliefs of management. Such statements are subject to risks and
uncertainties that may cause actual results to be materially different from
those that may be implied by such forward-looking statements contained in this
press release. Important factors that could result in such differences
include: changes in general economic, business and competitive conditions,
effects of future judicial decisions, changes in regulation, exchange rate
fluctuations and hiring and retention of its employees.
SOURCE UCB
Bert Kelly, Manager, U.S. Communications & Public Relations, UCB, M: +1
404.784.6303, bert.Kelly@ucb-group.com
