ORENCIA is the only biologic treatment for
moderate to severe rheumatoid arthritis that is approved in three
administration options – IV infusion, prefilled syringe, and
autoinjector1-10
New ORENCIA ClickJect Autoinjector offers
accurate dose self-injection with push button operation, and
confirmation that the full dose has been injected11
Patients with moderate to severe RA who tested
the ClickJect Autoinjector found the design comfortable and
easy-to-use
Bristol-Myers Squibb Company (NYSE:BMY) announced today the
commercial launch of the ORENCIA ClickJectTM Autoinjector, a new
self-administered autoinjector for adults with moderate to severe
rheumatoid arthritis (RA). The ORENCIA ClickJect delivers 125 mg of
subcutaneous (SC) ORENCIA with push button operation and
injection confirmation, which may reduce the possibility of user
errors. The ORENCIA ClickJect has an ergonomic design and non-slip
grip that may allow for control by dexterity-compromised
patients.11 ORENCIA is the only RA biologic that offers three
administration options: IV infusion, prefilled syringe and
Autoinjector.1-10 ORENCIA is a prescription medicine 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 rheumatoid arthritis. ORENCIA should not be administered
concomitantly with tumor necrosis factor (TNF) antagonists, and is
not recommended for use concomitantly with other biologic RA
therapy, such as anakinra.
“Today’s launch of the ORENCIA ClickJect is an example of our
continued commitment to offering patients with moderate to severe
rheumatoid arthritis a treatment option that may be appropriate for
them, now available as an autoinjector,” said Chris Boerner, Head
of U.S. Commercial, Bristol-Myers Squibb. “This approval offers
more options for healthcare providers and members of the arthritis
community to consider when selecting the optimal treatment and
administration option for each individual.”
In a summative study, patients (n=48) evaluated the ORENCIA
ClickJect Autoinjector usability and acceptability based on key
attributes, including comfort (patients, P=0.0157), control
(patients, P=0.0002), ease of use (patients, P=0.0210) and
confidence of dose (patients, P=0.896). The mean scores for the
device across criteria ranged from 6.4-6.9 with the patient group,
where user experience was measured using a 7-point scale (1=very
unacceptable, 4=neutral, 7=very acceptable). Studies were conducted
by an independent company and participants were informed that a new
RA autoinjector was being tested but were blinded to the intended
drug and sponsor identity.11
For patients with early, rapidly progressing moderate to severe
RA, treatment with ORENCIA may be an appropriate option. In a
12-month, multinational, double-blind, randomized, Phase IIIB study
of methotrexate (MTX)-naïve patients with early, rapidly
progressing RA, ORENCIA IV + MTX demonstrated significant efficacy
vs MTX alone for those with moderate to severe RA. The study,
AGREE, met its co-primary endpoints as defined by proportion of
patients achieving DAS28-CRP < 2.6 at 1 year (41% vs 23%,
P<0.001) and inhibition of radiographic progression at 1 year
(mean change in total symptoms scores: 0.6 vs 1.1, P=0.04).
Headache, upper respiratory tract infection, nasopharyngitis, and
nausea were the most commonly reported adverse events occurring at
a rate of ≥ 10% in patients taking ORENCIA in the adult RA clinical
studies.13
“Rheumatoid arthritis often affects joints in the hand and
impairs dexterity.12 Through the new ORENCIA ClickJect, we are able
to offer the proven benefits of ORENCIA in an accurate dose
self-injection and provide an additional option for healthcare
providers when selecting treatment options for their patients,”
said Sheila Kelly, M.D., U.S. ORENCIA Medical Lead, Bristol-Myers
Squibb.
The new ORENCIA ClickJect comes with push button operation and
step-by-step instructions to help the injection process for
patients. The Autoinjector's sturdy, lightweight design may allow
patients with RA to firmly hold, operate and control the device.11
It automatically delivers the full dose of ORENCIA with one push of
a button and the user holding for fifteen seconds. Also, the
ClickJect Autoinjector’s large viewing window and blue indicator
help confirm the full dose of ORENCIA has been injected.11 The
ClickJect’s Autoinjector’s transparent tip automatically locks and
covers the needle after injection to help prevent accidental needle
sticks.11
Physicians and patients interested in receiving more information
about the ORENCIA ClickJect should visit www.ORENCIAHCP.com or call
1-800-ORENCIA.
About Rheumatoid
Arthritis
Rheumatoid arthritis (RA) is a systemic, chronic, autoimmune
disease characterized by inflammation in the lining of the joints
(or synovium), causing joint damage with chronic pain, stiffness,
and swelling.12 RA causes limited range of motion and decreased
joint function. The condition is more common in women than in men,
who account for 75% of patients diagnosed with RA.12
About ORENCIA
ORENCIA SC and IV 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 rheumatoid arthritis.
ORENCIA may be used as monotherapy or concomitantly with
disease-modifying antirheumatic drugs (DMARDs) other than tumor
necrosis factor (TNF) antagonists.
ORENCIA IV is indicated for reducing signs and symptoms in
pediatric patients 6 years of age and older with moderately to
severely active polyarticular juvenile idiopathic arthritis.
ORENCIA IV may be used as monotherapy or concomitantly with
methotrexate (MTX). ORENCIA SC has not been studied in pediatric
patients.
ORENCIA should not be administered concomitantly with TNF
antagonists.
ORENCIA is not recommended for use concomitantly with other
biologic rheumatoid arthritis (RA) therapy, such as anakinra.
ORENCIA is intended for use under the guidance of a physician or
healthcare practitioner.
Indications/Usage and Important Safety Information for
ORENCIA® (abatacept)
Indication and Usage
Adult Rheumatoid Arthritis (RA): ORENCIA® (abatacept) 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® (abatacept)
is indicated for reducing signs and symptoms in pediatric patients
aged 6 years 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 concerning SC ORENCIA: The safety and efficacy of SC
ORENCIA have not been studied in patients under 18 years of
age.
Please see Full Prescribing Information at
http://packageinserts.bms.com/pi/pi_orencia.pdf.
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 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,
2015 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.
References:
- Enbrel Prescribing Information. U.S.
Food and Drug Administration. 2015. Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103795s5548lbl.pdf.
Accessed on: June 23, 2016.
- Humira Prescribing Information. U.S.
Food and Drug Administration. 2011. Available at:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125057s0276lbl.pdf.
Accessed on: June 23, 2016.
- Actemra Prescribing Information. U.S.
Food and Drug Administration. 2010. Available at:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125276lbl.pdf.
Accessed on: June 23, 2016.
- Xeljanz Prescribing Information. U.S.
Food and Drug Administration. 2012. Available at:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203214s000lbl.pdf.
Accessed on: June 23, 2016.
- Rituxan Prescribing Information. U.S.
Food and Drug Administration. 2010. Available at:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103705s5311lbl.pdf.
Accessed on: June 23, 2016.
- Cimzia Prescribing Information. U.S.
Food and Drug Administration. 2008. Available at:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125160s000lbl.pdf.
Accessed on: June 23, 2016.
- Kineret Prescribing Information. U.S.
Food and Drug Administration. 2012. Available at:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103950s5136lbl.pdf.
Accessed on: June 23, 2016.
- Remicade Prescribing Information. U.S.
Food and Drug Administration. 2011. Available at:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103772s5281lbl.pdf.
Accessed on: June 23, 2016.
- Simponi Prescribing Information. U.S.
Food and Drug Administration. 2011. Available at:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125289s0064lbl.pdf.
Accessed on: June 23, 2016.
- Orencia Prescribing Information.
Bristol-Myers Squibb. 2016. Available at:
http://packageinserts.bms.com/pi/pi_orencia.pdf. Accessed on: June
23, 2016.
- Schiff M et al. Usability and
Acceptability of the Abatacept Pre-Filled Autoinjector for the
Subcutaneous Treatment of Rheumatoid Arthritis. Advances in
Therapy. 2016.
- Rheumatoid Arthritis. American College
of Rheumatology. August 2012.
- Westhovens R, Robles M, Ximenes AC, et
al. Clinical efficacy and safety of abatacept in methotrexate-naïve
patients with early rheumatoid arthritis and poor prognostic
factors. Ann Rheum Dis. 2009;68(12):1870-1877.
ORENCIA® and ClickJect are trademarks of Bristol-Myers Squibb
Company.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160720005384/en/
Bristol-Myers Squibb CompanyMedia:Erin McMaster,
609-897-2657erin.mcmaster@bms.comorInvestors:Bill
Szablewski, 609-252-5894william.szablewski@bms.com
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From Apr 2024 to May 2024
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From May 2023 to May 2024