New prefilled syringe option can be
administered at home
Bristol-Myers Squibb Company (NYSE:BMY) announced today the
availability of a new FDA-approved subcutaneous (SC) ORENCIA
administration option for use in patients 2 years of age and older
with moderately to severely active polyarticular Juvenile
Idiopathic Arthritis (JIA).1 The new prefilled syringe offers
physicians, patients, and caregivers of these patients the option
of ORENCIA treatment that can be administered at home.1 In 2008,
ORENCIA IV was the first FDA-approved IV biologic for use in
patients 6 years of age and older with moderately to severely
active polyarticular JIA.
“The data supporting this new FDA approved prefilled syringe
provide a scientific basis for the dosing, efficacy and safety of
subcutaneous abatacept in JIA and add to the growing body of
clinical evidence for patients 2 years of age and older living with
this difficult autoimmune disease,” said Daniel J. Lovell, M.D.,
M.P.H., Joseph E. Levinson Endowed Chair of Pediatric Rheumatology
and Professor of Pediatrics, University of Cincinnati Medical
Center. “Importantly, subcutaneous abatacept also provides
physicians a new administration option to offer their
patients.”
JIA is the most common type of arthritis in children and a
condition that makes it difficult to do everyday things, and may
eventually result in disability.2 ORENCIA SC is a prescription
medicine that is indicated for reducing signs and symptoms in
patients 2 years of age and older with moderately to severely
active JIA.1 ORENCIA may be used as monotherapy or concomitantly
with methotrexate (MTX).1 ORENCIA should not be administered
concomitantly with TNF antagonists, and is not recommended for use
concomitantly with other biologic RA therapy, such as
anakinra.1
ORENCIA SC should be initiated without an IV loading dose and
administered once-weekly using weight-tiered dosing: 50 mg/0.4 mL
syringe (for patients 10 to <25 kg), 87.5 mg/0.7 mL syringe (for
patients 25 to <50 kg) and 125 mg/mL syringe (for patients ≥50
kg).1 Dosage is to be determined by a physician.1 Patients or
caregivers should receive training on the right way to prepare and
inject ORENCIA.1
It is not known if ORENCIA SC is safe and effective in children
under 2 years of age.1 Intravenous dosing has not been studied in
patients younger than 6 years of age.1 The safety and efficacy of
ORENCIA ClickJect TM Autoinjector for subcutaneous injection has
not been studied in patients under 18 years of age.
In Study JIA-2, an open-label, phase 3 study with a 4-month
short-term period (n=205) and a 20 month open-label extension
period, the primary objective was evaluation of PK in order to
support the extrapolation of efficacy based on exposure to ORENCIA
supported by descriptive efficacy. Pharmacokinetics, safety and
efficacy of SC ORENCIA were assessed in patients ages 2 to 17 years
with JIA and an inadequate response to at least one nonbiologic or
biologic DMARD. At study entry, 80% of patients were receiving
methotrexate and remained on a stable dose of methotrexate.1 JIA
ACR 30, 50, and 70 response rates at 4 months were 81%, 71% and
53%, respectively and were observed to be consistent with the
results from the IV study, JIA-1.3
In general, the adverse events observed in pediatric patients
with Juvenile Idiopathic Arthritis were similar in frequency and
type to those seen in adult patients.1
In the intravenous Study JIA-1, the overall frequency of adverse
events in the 4-month, lead-in, open-label period of the study was
70%; infections occurred at a frequency of 36%. The most common
infections were upper respiratory tract infection and
nasopharyngitis. The infections resolved without sequelae, and the
types of infections were consistent with those commonly seen in
outpatient pediatric populations. Other events that occurred at a
prevalence of at least 5% were headache, nausea, diarrhea, cough,
pyrexia, and abdominal pain. A total of 6 serious adverse events
(acute lymphocytic leukemia, ovarian cyst, varicella infection,
disease flare [2], and joint wear) were reported during the initial
4 months of treatment with ORENCIA IV. One case of a
hypersensitivity reaction (0.5%) was reported. During Periods A, B,
and C of Study JIA-1, acute infusion-related reactions occurred at
a frequency of 4%, 2%, and 3%, respectively, and were consistent
with the types of events reported in adults. Upon continued
treatment in the open-label extension period, the types of adverse
events were similar in frequency and type to those seen in adult
patients, except for a single patient diagnosed with multiple
sclerosis while on open-label treatment.1
The safety experience and immunogenicity for ORENCIA
administered subcutaneously in Study JIA-2 were consistent with the
intravenous Study JIA-1.1 There were no reported cases of
hypersensitivity reactions and local injection-site reactions
occurred at a frequency of 4.4%.1
“Juvenile Idiopathic Arthritis can cause pain, stiffness and
swelling that may make it difficult for children to do everyday
things like playing with friends or riding a bike.2 Understandably,
the condition can impact the entire family,”4 said Brian J. Gavin,
Vice President, ORENCIA Development Lead at Bristol-Myers Squibb.
“We’re proud to be able to provide a new subcutaneous
administration option1 for ORENCIA, a proven choice for patients
with JIA, as part of our commitment to advancing immunoscience
research to address unmet needs and supporting JIA patients and
their families.”
Physicians, patients, and parents interested in learning more
about ORENCIA for moderate to severe JIA should visit
www.ORENCIA.com or call 1-800-ORENCIA.
About Juvenile Idiopathic
Arthritis
Affecting more than 50,000 children in the United States,5
Juvenile Idiopathic Arthritis (JIA) is the most common type of
arthritis in children.2 Potentially involving one or many joints,
JIA may cause damage that makes it difficult to do everyday things
and may eventually result in disability.2
Indication and Important Safety Information for
ORENCIA® (abatacept)
Indication and Usage
Adult Rheumatoid Arthritis (RA): ORENCIA is
indicated for reducing signs and symptoms, inducing major clinical
response, inhibiting the progression of structural damage, and
improving physical function in adult patients with moderately to
severely active RA. ORENCIA may be used as monotherapy or
concomitantly with disease-modifying, anti-rheumatic drugs (DMARDs)
other than tumor necrosis factor (TNF) antagonists.
Juvenile Idiopathic Arthritis (JIA): ORENCIA is
indicated for reducing signs and symptoms in patients 2 years of
age and older with moderately to severely active polyarticular JIA.
ORENCIA may be used as monotherapy or concomitantly with
methotrexate (MTX).
Important Limitations of Use: ORENCIA should not be
administered concomitantly with TNF antagonists, and is not
recommended for use concomitantly with other biologic RA therapy,
such as anakinra.
Important Safety Information for
ORENCIA®
(abatacept)
Concomitant Use with TNF Antagonists: Concurrent
therapy with ORENCIA and a TNF antagonist is not recommended. In
controlled clinical trials, adult patients receiving concomitant
intravenous ORENCIA and TNF antagonist therapy experienced more
infections (63%) and serious infections (4.4%) compared to patients
treated with only TNF antagonists (43% and 0.8%, respectively),
without an important enhancement of efficacy.
Hypersensitivity: Anaphylaxis or anaphylactoid
reactions can occur during or after an infusion and can be
life-threatening. There were 2 cases (<0.1%; n=2688) of
anaphylaxis or anaphylactoid reactions in clinical trials with
adult RA patients treated with intravenous ORENCIA. Other reactions
potentially associated with drug hypersensitivity, such as
hypotension, urticaria, and dyspnea, each occurred in <0.9% of
patients. There was one case of a hypersensitivity reaction with
ORENCIA in JIA clinical trials (0.5%; n=190). In postmarketing
experience, a case of fatal anaphylaxis following the first
infusion of ORENCIA was reported. Appropriate medical support
measures for treating hypersensitivity reactions should be
available for immediate use. If an anaphylactic or other serious
allergic reaction occurs, administration of ORENCIA should be
stopped immediately and permanently discontinued, with appropriate
therapy instituted.
Infections: Serious infections, including sepsis and
pneumonia, have been reported in patients receiving ORENCIA. Some
of these infections have been fatal. Many of the serious infections
have occurred in patients on concomitant immunosuppressive therapy
which, in addition to their underlying disease, could further
predispose them to infection. Caution should be exercised in
patients with a history of infection or underlying conditions which
may predispose them to infections. Treatment with ORENCIA should be
discontinued if a patient develops a serious infection. Patients
should be screened for tuberculosis and viral hepatitis in
accordance with published guidelines, and if positive, treated
according to standard medical practice prior to therapy with
ORENCIA.
Immunizations: Live vaccines should not be given
concurrently with ORENCIA or within 3 months of its
discontinuation. The efficacy of vaccination in patients receiving
ORENCIA is not known. ORENCIA may blunt the effectiveness of some
immunizations. It is recommended that JIA patients be brought up to
date with all immunizations in agreement with current immunization
guidelines prior to initiating therapy with ORENCIA.
Use in Patients with Chronic Obstructive Pulmonary Disease
(COPD): Adult COPD patients treated with ORENCIA developed
adverse events more frequently than those treated with placebo (97%
vs 88%, respectively). Respiratory disorders occurred more
frequently in patients treated with ORENCIA compared to those on
placebo (43% vs 24%, respectively), including COPD exacerbation,
cough, rhonchi, and dyspnea. A greater percentage of patients
treated with ORENCIA developed a serious adverse event compared to
those on placebo (27% vs 6%), including COPD exacerbation [3 of 37
patients (8%)] and pneumonia [1 of 37 patients (3%)]. Use of
ORENCIA in patients with RA and COPD should be undertaken with
caution, and such patients monitored for worsening of their
respiratory status.
Blood Glucose Testing: ORENCIA for intravenous
administration contains maltose, which may result in falsely
elevated blood glucose readings on the day of infusion when using
blood glucose monitors with test strips utilizing glucose
dehydrogenase pyrroloquinoline quinone (GDH-PQQ). Consider using
monitors and advising patients to use monitors that do not react
with maltose, such as those based on glucose dehydrogenase nicotine
adenine dinucleotide (GDH-NAD), glucose oxidase or glucose
hexokinase test methods. ORENCIA for subcutaneous (SC)
administration does not contain maltose; therefore, patients do not
need to alter their glucose monitoring.
Pregnancy: There are no adequate and well-controlled
studies of ORENCIA use in pregnant women and the data with ORENCIA
use in pregnant women are insufficient to inform on drug-associated
risk. A pregnancy registry has been established to monitor
pregnancy outcomes in women exposed to ORENCIA during pregnancy.
Healthcare professionals are encouraged to register patients by
calling 1-877-311-8972.
Lactation: There is no information regarding the
presence of abatacept in human milk, the effects on the breastfed
infant, or the effects on milk production. However, abatacept was
present in the milk of lactating rats dosed with abatacept.
Most Serious Adverse Reactions: Serious infections (3%
ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1%
placebo).
Malignancies: The overall frequency of malignancies was
similar between adult patients treated with ORENCIA or placebo.
However, more cases of lung cancer were observed in patients
treated with ORENCIA (0.2%) than those on placebo (0%). A higher
rate of lymphoma was seen compared to the general population;
however, patients with RA, particularly those with highly active
disease, are at a higher risk for the development of lymphoma. The
potential role of ORENCIA in the development of malignancies in
humans is unknown.
Most Frequent Adverse Events (≥10%): Headache, upper
respiratory tract infection, nasopharyngitis, and nausea were the
most commonly reported adverse events in the adult RA clinical
studies. Other events reported in ≥5% of JIA patients were
diarrhea, cough, pyrexia, and abdominal pain. In general, the
adverse events in pediatric patients were similar in frequency and
type to those seen in adult patients.
Note ORENCIA administration options: Intravenous dosing
has not been studied in patients younger than 6 years of age. The
safety and efficacy of ORENCIA ClickJect™ Autoinjector for
subcutaneous injection has not been studied in patients under 18
years of age.
Please click here to see the Full Prescribing
Information.
ORENCIA® (abatacept) is a registered trademark of Bristol-Myers
Squibb Company. ClickJect™ is a trademark of Bristol-Myers Squibb
Company.
About Bristol-Myers Squibb
Immunoscience
With a robust pipeline of immunomodulatory therapies,
Bristol-Myers Squibb is committed to the discovery and development
of transformational medicines for patients suffering from
immune-mediated disease. As we learn more about the immune system
in diseases with substantial unmet medical needs, the potential for
new therapies that modulate the immune system continues to drive
our research efforts.
About Bristol-Myers
Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol-Myers Squibb, visit us at BMS.com or
follow us on LinkedIn, Twitter, YouTube and Facebook.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that
term is defined in the Private Securities Litigation Reform Act of
1995 regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are based
on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
any of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking statement
can be guaranteed. Forward-looking statements in this press release
should be evaluated together with the many uncertainties that
affect Bristol-Myers Squibb's business, particularly those
identified in the cautionary factors discussion in Bristol-Myers
Squibb's Annual Report on Form 10-K for the year ended December 31,
2016 in our Quarterly Reports on Form 10-Q and our Current Reports
on Form 8-K. Bristol-Myers Squibb undertakes no obligation to
publicly update any forward-looking statement, whether as a result
of new information, future events or otherwise.
References1. ORENCIA®
Prescribing Information. Bristol-Myers Squibb Company, Princeton,
NJ.2. Centers for Disease Control and Prevention. Arthritis Types.
Available at: https://www.cdc.gov/arthritis/basics/types.html.
Accessed on February 22, 2017.3. Ruperto N, Lovell D, Tzaribachev
N., et al. Subcutaneous Abatacept in Patients with Polyarticular
Juvenile Idiopathic Arthritis and Inadequate Response To Biologic
or Non-Biologic Disease-Modifying Antirheumatic Drugs:
Pharmacokinetics, Efficacy and Safety. Annals of the Rheumatic
Diseases. 2016;75(Suppl 2).4. National Institute of Arthritis and
Musculoskeletal and Skin Diseases. What is Juvenile Arthritis –
Fast Facts: An Easy-to-Read Series of Publications for the Public.
Available at:
https://www.niams.nih.gov/Health_Info/Juv_Arthritis/juvenile_arthritis_ff.asp.
Accessed on: March 9, 2017.5. The Arthritis National Research
Foundation Website. What is Juvenile Arthritis? Available at:
http://www.curearthritis.org/juvenile-arthritis/. Accessed on March
22, 2017.
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version on businesswire.com: http://www.businesswire.com/news/home/20170608005427/en/
Bristol-Myers Squibb CompanyMedia:Erin McMaster,
609-955-2253erin.mcmaster@bms.comorInvestors:Bill Szablewski,
609-252-5894william.szablewski@bms.com
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