FDA Approves REMICADE(R) as First and Only Biologic to Treat Ulcerative Colitis |
Approval Marks Major Treatment Breakthrough for Patients With Debilitating
Disease
HORSHAM, Pa., Sept. 16 /PRNewswire/ -- Centocor, Inc. announced today that
REMICADE(R) (infliximab) has been approved by the U.S. Food and Drug
Administration (FDA) for the treatment of ulcerative colitis (UC), making
REMICADE the first and only biologic approved for UC, a chronic inflammatory
bowel disease (IBD).
REMICADE is now indicated for reducing signs and symptoms, achieving
clinical remission and mucosal healing, and eliminating corticosteroid use in
patients with moderately to severely active UC who have had an inadequate
response to conventional therapy. This is an unprecedented milestone in the
treatment of moderate-to-severe UC; to date, no therapy has ever been
indicated for mucosal healing and eliminating the use of corticosteroids.
"The approval of REMICADE for the treatment of UC represents a major
breakthrough for patients suffering from this often debilitating disease,"
said William J. Sandborn, M.D., professor of medicine, Mayo Clinic College of
Medicine and head of the IBD Interest Group and director of the IBD Clinical
Research Unit at Mayo Medical Center. "Not only did many patients in clinical
trials experience a significant reduction in the occurrence of symptom flare-
ups with REMICADE, some achieved clinical remission and mucosal healing as
well. This is welcome news for these patients whose only option otherwise may
have been surgery to remove their colons."
REMICADE's efficacy in the treatment of IBD is well established. First
approved in the United States for the treatment of Crohn's disease (CD) in
1998, REMICADE remains the only anti-tumor necrosis factor (TNF-alpha) therapy
indicated for the treatment of CD. With this new approval for the treatment
of ulcerative colitis, REMICADE is now the only biologic indicated for the
treatment of both types of inflammatory bowel diseases, CD and UC.
In addition to UC and CD, REMICADE is also indicated for the treatment of
rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. More
than 600,000 patients have been treated with REMICADE worldwide. This new
approval for the treatment of UC continues to demonstrate the benefit of
REMICADE across immune-mediated inflammatory diseases.
UC is a debilitating chronic disease affecting more than 500,000
Americans, for whom there is no medical cure, and while UC affects more people
in the United States than multiple sclerosis or cystic fibrosis, general
awareness of the disease is lower. Characterized by inflammation and
ulceration of the inner lining of the colon, UC symptoms can often include
unwanted weight loss, severe - sometimes uncontrollable - bloody diarrhea,
fatigue and frequent abdominal pain. For some patients, symptoms may lead to
surgical removal of the colon or to secondary complications such as colorectal
cancer.
"We are optimistic that the use of a treatment like REMICADE will provide
many people with relief from the debilitating symptoms that have had such a
profound impact on their lives," said Rodger DeRose, president and CEO of the
Crohn's & Colitis Foundation of America. "Results from a recent patient
survey revealed that UC affects many aspects of people's lives, from their
relationships with families and employers to the ability to participate in
social activities."
Clinical Trial Information: ACT 1 and ACT 2
The approval of REMICADE is based on positive results seen in two
randomized, placebo-controlled pivotal Phase 3 clinical trials, ACT 1 and ACT
2, which were conducted to evaluate the safety and efficacy of REMICADE in
people with active, moderate-to-severe UC.
In each trial, 364 patients with active UC who were unresponsive to at
least one standard therapy - including corticosteroids, immunosuppressants or
5-ASAs - were enrolled. Patients in ACT 1 and ACT 2 had evidence of moderate
or severe UC (total Mayo score of 6 to 12 and an endoscopy score greater than
or equal to 2). In both trials, patients were randomized to receive placebo
or REMICADE 5 mg/kg or 10 mg/kg. ACT 1 patients received the study agent at
weeks 0, 2 and 6 and then every 8 weeks through week 46 and had their last
evaluations at week 54. ACT 2 patients received the study agent at weeks 0, 2
and 6 and then every 8 weeks through week 22 and had their last evaluations at
week 30.
In ACT 1, significantly higher proportions of patients receiving REMICADE
5 mg/kg (69 percent) and 10 mg/kg (62 percent) achieved clinical response at
week 8 versus placebo-treated patients (37 percent; P<0.001 for both). In
addition, at week 30, 52 percent of patients in the 5 mg/kg and 51 percent of
patients in the 10 mg/kg REMICADE treatment group were in clinical response
versus 30 percent of placebo-treated patients (P<0.001 and P<0.01,
respectively). At week 8, 39 percent and 32 percent of patients treated with
REMICADE 5 mg/kg and 10 mg/kg, respectively, were in clinical remission
compared to 15 percent of placebo-treated patients (P<0.001 and P<0.01).
These differences in remission rates persisted at week 30 (34 percent, 5
mg/kg; 37 percent, 10 mg/kg versus 16 percent, placebo; P<0.001 for both).
Mucosal healing was achieved at week 8 in 62 percent and 59 percent of
patients receiving REMICADE 5 mg/kg and 10 mg/kg, respectively, versus 34
percent of placebo-treated patients (P<0.001). This difference in mucosal
healing was maintained at week 30 (50 percent, 5 mg/kg; 49 percent, 10 mg/kg
versus 25 percent, placebo; P<0.001 for both). The proportion of patients who
were able to discontinue corticosteroids while in clinical remission at week
30 was greater in both REMICADE groups compared to the placebo group (24
percent, 5 mg/kg; 19 percent, 10 mg/kg; 10 percent, placebo; P=0.030 and
P=0.125, respectively).
In ACT 2, significantly higher proportions of patients receiving REMICADE
5 mg/kg (65 percent) and 10 mg/kg (69 percent) were in clinical response at
week 8 versus 29 percent who received placebo (P<0.001 for both). At week 30,
47 percent of patients receiving REMICADE 5 mg/kg and 60 percent receiving 10
mg/kg were in clinical response versus 26 percent of patients receiving
placebo (P<0.001 for both). Clinical remission was achieved at week 8 in 34
percent and 28 percent of REMICADE 5 and 10 mg/kg patients, respectively,
compared to 6 percent of placebo-treated patients (P<0.001 for both).
Differences in remission rates persisted at week 30 (26 percent, 5 mg/kg; 36
percent, 10 mg/kg; 11 percent, placebo; P<0.01 and P<0.001). Mucosal healing
was achieved at week 8 in 60 percent and 62 percent of patients receiving
REMICADE 5 mg/kg and 10 mg/kg, respectively, compared to 31 percent of
placebo-treated patients (P<0.001 for both). Mucosal healing at week 30 was
achieved in 46 percent and 57 percent of patients receiving REMICADE 5 and 10
mg/kg, respectively, compared to 30 percent of placebo-treated patients
(P<0.01 and P<0.001). The proportion of patients who were able to discontinue
corticosteroids while in clinical remission at week 30 was significantly
greater in both REMICADE groups compared with the placebo group (18 percent, 5
mg/kg; 27 percent, 10 mg/kg; 3 percent, placebo; P=0.010 and P<0.001,
respectively).
The serious adverse events reported in these trials were similar to those
reported in previous REMICADE clinical trials. (See Important Safety
Information below).
About REMICADE
REMICADE is the global market leader among anti-tumor necrosis factor
alpha (TNF-alpha) therapies and the only agent approved for the treatment of
both rheumatoid arthritis (RA) and CD in North America, the EU and Japan.
In the U.S., REMICADE, in combination with methotrexate, is indicated for
reducing signs and symptoms, inhibiting the progression of structural damage
and improving physical function in patients with moderately to severely active
RA. REMICADE is the only biologic indicated for the treatment of patients
with moderately-to-severely active CD who have had an inadequate response to
conventional therapy. REMICADE is also indicated for reducing the number of
draining enterocutaneous and rectovaginal fistulas and maintaining fistula
closure in patients with fistulizing CD. In December 2004, REMICADE was
approved for the treatment of active ankylosing spondylitis in the U.S. On
May 13, 2005, REMICADE was approved for the treatment of psoriatic arthritis.
REMICADE is unique among available anti-TNF biologic therapies. Unlike
self-administered therapies that require patients to inject themselves
frequently, REMICADE is the only anti-TNF biologic administered directly by
caregivers in the clinic or office setting. In RA and CD, REMICADE is a two-
hour infusion administered every 8 weeks, following a standard induction
regimen that requires treatment at weeks 0, 2 and 6. As a result, REMICADE
patients may require as few as six treatments each year. In ankylosing
spondylitis, REMICADE is a two-hour infusion (5 mg/kg) administered every 6
weeks, following a standard induction regimen that requires treatment at weeks
0, 2, and 6. The safety and efficacy of REMICADE have been well established
in clinical trials over the past 12 years and through commercial experience
with over a half-million patients treated worldwide.
Important Safety Information
Many people with heart failure should not take REMICADE; so prior to
treatment you should discuss any heart condition with your doctor. Tell your
doctor right away if you develop new or worsening symptoms of heart failure
(such as shortness of breath or swelling of your ankles or feet). There are
reports of serious infections, including tuberculosis (TB), sepsis and
pneumonia. Some of these infections have been fatal. Tell your doctor if you
have had recent or past exposure to people with TB. Your doctor will evaluate
you for TB and perform a skin test. If you have latent (inactive) TB, your
doctor should begin TB treatment before you start REMICADE. REMICADE can
lower your ability to fight infections, so if you are prone to or have a
history of infections, or develop any signs of an infection such as fever,
fatigue, cough, or the flu while taking REMICADE, tell your doctor right away.
Also tell your doctor if you have lived in a region where histoplasmosis or
coccidioidomycosis is common.
There have been rare cases of serious liver injury in people taking
REMICADE, some fatal. Contact your doctor immediately if you develop symptoms
such as jaundice (yellow skin and eyes), dark brown urine, right-sided
abdominal pain, fever, or severe fatigue.
Blood disorders have been reported, some fatal. Tell your doctor if you
develop possible signs of blood disorders such as persistent fever, bruising,
bleeding, or paleness while taking REMICADE. Nervous system disorders have
also been reported. Tell your doctor if you have or have had a disease that
affects the nervous system, or if you experience any numbness, weakness,
tingling, or visual disturbances while taking REMICADE.
Reports of a type of blood cancer called lymphoma in patients on REMICADE
or other TNF blockers are rare but occur more often than expected for people
in general. People who have been treated for rheumatoid arthritis, Crohn's
disease, ankylosing spondylitis, or psoriatic arthritis for a long time,
particularly those with highly active disease may be more prone to develop
lymphoma. Cancers, other than lymphoma, have also been reported. If you take
REMICADE or other TNF blockers, your risk for developing lymphoma or other
cancers may increase. You should also tell your doctor if you have had or
develop lymphoma or other cancers while you are taking REMICADE.
Serious infusion reactions have been reported with REMICADE, including
hives, difficulty breathing, and low blood pressure. Reactions have occurred
during or after infusions. In clinical studies, some people experienced the
following common side effects: respiratory infections (that may include sinus
infections and sore throat), coughing, and stomach pain or mild reactions to
infusion such as rash or itchy skin.
Please read important information about REMICADE, including full
prescribing information at http://www.remicade.com.
About Centocor
Centocor is harnessing the power of world-leading research and
biomanufacturing to deliver innovative biomedicines that transform patients'
lives. Centocor has already brought innovation to the treatment of Crohn's
disease, rheumatoid arthritis, ankylosing spondylitis, and psoriatic
arthritis.
The world leader in monoclonal antibody production and technology,
Centocor has brought critical biologic therapies to patients suffering from
debilitating immune disorders. Centocor, Inc. is a wholly owned subsidiary of
Johnson & Johnson, a worldwide manufacturer of healthcare products.
Centocor discovered REMICADE and has exclusive marketing rights to the
product in the United States. Schering-Plough Corporation has rights to
market REMICADE in all countries outside of the United States, except in Japan
and parts of the Far East where Tanabe Seiyaku, Ltd. markets the product.
SOURCE Centocor, Inc.
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CONTACT:
Michael Parks, Centocor, +1-215-325-4010, or
Cell: +1-215-983-8000
