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ORENCIA® (abatacept) Supplemental
Biologics License Application For Juvenile Idiopathic Arthritis
Accepted By FDA For Filing And Review
12 Aug 2007
As edited by Joint-Pain-Forum.com
Bristol-Myers Squibb Company (NYSE: BMY) today announced that
the U.S. Food and Drug Administration (FDA) has accepted, for filing
and review, the supplemental biologics license application (sBLA) for
ORENCIA® (abatacept) for the treatment of pediatric patients with
juvenile idiopathic arthritis (JIA) who have had an inadequate response
to one or more disease-modifying anti-rheumatic drugs (DMARDs) such as
methotrexate (MTX) or tumor necrosis factor (TNF) antagonists.
This sBLA is based on data from a double-blind, randomized trial that
consisted of three periods: a four-month open-label lead-in treatment
period in which all participants (6-17 years old) received ORENCIA and
both clinical response and safety were assessed (Period A), a six-month
randomized double- blind withdrawal phase in which responders received
either ORENCIA or placebo and time to disease flare and safety were
assessed (Period B), and an open- label phase in which all participants
received ORENCIA in order to assess long-term efficacy and safety
(Period C).
ORENCIA, which was discovered and developed by Bristol-Myers Squibb, is
currently approved for use in adults with moderate to severe rheumatoid
arthritis (RA) who have had an inadequate response to one or more
DMARDs such as MTX or TNF antagonists. ORENCIA is a selective modulator
of a co- stimulatory signal required for full T-cell activation.
About Juvenile Idiopathic Arthritis
JIA -- also commonly known as juvenile rheumatoid arthritis (JRA) -- is
a chronic, autoimmune disease, causing chronic pain, stiffness and
swelling of the joints, which may ultimately lead to joint damage and
deformities. The disease usually begins before the age of 16 and may
affect up to 1 child in every 1,000 in the United States.
Important Safety Information about ORENCIA® (abatacept)
Before receiving treatment with ORENCIA individuals should tell their
doctor if they are taking a TNF blocker (e.g., Enbrel®, Humira®,
Remicade®) to treat rheumatoid arthritis (RA). ORENCIA should not be
taken with these medications because of a higher chance of getting a
serious infection. Individuals should also tell their doctor if they
are taking Kineret® to treat RA. ORENCIA should not be taken with
Kineret. People taking ORENCIA should notify their doctor if they are
taking any other medications including hormones, over-the-counter
medicines, vitamins, supplements or herbal products.
Individuals should let their doctor know if they have any kind of
infection including an infection that is in only one place of the body
(such as an open cut or sore) or an infection that is in the whole body
(such as the flu). Having an infection could increase the risk for
serious side effects from ORENCIA. It is also important for individuals
to let their doctor know if they have an infection that won't go away
or a history of infections that keep coming back.
People who have had tuberculosis (TB), a positive skin test for TB,
recent close contact with someone who has had TB or develop any of the
symptoms of TB (a dry cough that doesn't go away, weight loss, fever,
night sweats) should call their doctor right away. Before starting
treatment with ORENCIA, a doctor may examine the individual for TB or
perform a skin test.
In addition, individuals should let their doctor know if they are
scheduled to have surgery or any vaccination or have recently received
a vaccination. People should inform their doctor if they have a history
of chronic obstructive pulmonary (lung) disease (COPD). Taking ORENCIA
may cause COPD symptoms to get worse.
People who have diabetes and use a blood glucose monitor to check their
sugar levels should tell their doctor. The infusion of ORENCIA contains
maltose, a sugar that can give falsely high blood glucose readings with
some monitors on the day the infusion is received. The doctor may
recommend a different monitor.
Women who are pregnant, planning to become pregnant or are thinking
about becoming pregnant should tell their doctor. It is not known if
ORENCIA® (abatacept) can harm an unborn baby. Women who are breast
feeding should also inform their doctor. They will need to decide to
either breast-feed or receive treatment with ORENCIA, but not both.
Important Information about Side Effects with ORENCIA
Like all medicines that affect your immune system, ORENCIA can cause
serious side effects. The possible serious side effects include serious
infections and allergic reactions. Also, rare cases of certain kinds of
cancers have been reported.
People taking ORENCIA are at increased risk for developing infections
including pneumonia, and other infections caused by viruses, bacteria,
or fungi. Individuals should call their doctor immediately if they feel
sick or get any infection during treatment with ORENCIA.
Allergic reactions are usually mild or moderate, generally occur within
the first 24 hours of an infusion, and include hives, swollen face,
eyelids, lips, tongue, throat, or trouble breathing. There have been
some serious allergic reactions reported after receiving an infusion of
ORENCIA.
There have been rare cases of certain kinds of cancer. The role of ORENCIA in the development of cancer is not known.
The more common side effects with ORENCIA are headache, upper respiratory tract infection, sore throat, and nausea.
For Full Prescribing Information, please visit http://www.orencia.com or http://www.bms.com
Dosing and Administration
ORENCIA is administered by a healthcare professional as a 30-minute
intravenous infusion at a fixed dose based on body weight range
approximating 10 mg/kg at day 0, 2 weeks, 4 weeks, and every 4 weeks
thereafter. Acute infusion-related reactions were experienced in nine
percent of people treated with ORENCIA and in six percent of people
treated with placebo. According to the full prescribing information,
the most frequently reported infusion- related adverse events (1
percent to 2 percent) were dizziness, headache, and hypertension. In
pivotal studies, premedications were not required. However, appropriate
medical support measures for the treatment of hypersensitivity
reactions should be available for immediate use in the event of a
reaction.
About ORENCIA® (abatacept)
ORENCIA is currently indicated in the United States for reducing signs
and symptoms, inducing major clinical response, inhibiting the
progression of structural damage, and improving physical function in
adults with moderately to severely active rheumatoid arthritis who have
had an inadequate response to one or more DMARDs, such as methotrexate
or TNF antagonists. ORENCIA may be used as monotherapy or concomitantly
with DMARDs other than TNF antagonists. ORENCIA should not be
administered concomitantly with TNF antagonists and is not recommended
for use concomitantly with anakinra.
Bristol-Myers Squibb Company is a global pharmaceutical and related
health care products company whose mission is to extend and enhance
human life.
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