If approved for the new indication,
ORENCIA would be the first biologic therapy with an EU
indication specifically applicable to the treatment of MTX-naive RA
patients with highly active and progressive disease
Would mark the first time that MRI
assessment of structural and inflammatory measures of disease
severity are cited in SmPC to support an RA indication
Bristol-Myers Squibb Company (NYSE:BMY) today announced that the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency has issued a positive opinion,
recommending the approval of ORENCIA® (abatacept) intravenous (IV)
infusion and subcutaneous (SC) injection, in combination with
methotrexate (MTX), for the treatment of highly active and
progressive disease in adult patients with rheumatoid arthritis
(RA) not previously treated with MTX. This CHMP recommendation will
now be reviewed by the European Commission (EC), which has the
authority to approve medicines for the European Union (EU).
If approved for this new indication, ORENCIA would be the first
biologic therapy with an EU indication specifically applicable to
the treatment of MTX-naive RA patients with highly active and
progressive disease. Studies of ORENCIA involving patients with
high disease activity accompanied by poor prognostic factors for
rapidly progressive disease (positive for anti-CCP antibodies,
and/or RF+, presence of baseline joint erosions) provided the
clinical trial evidence supporting the recommendation.
“This CHMP recommendation is particularly notable because it is
the first time that MRI-detected structural and inflammatory
measures of disease severity are cited as support for the proposed
RA indication,” said Paul Emery, M.A., M.D., F.R.C.P., F.Med.Sci.,
Arthritis Research UK Professor of Rheumatology and Head of the
Academic Division of Musculoskeletal Disease, Leeds Institute of
Molecular Medicine, University of Leeds, United Kingdom. “This is
consistent with mounting evidence supporting a paradigm shift in
how and when we initiate different forms of RA therapy,
particularly for those patients with progressive disease
accompanied by certain poor prognostic markers.”
Added Tom Huizinga, M.D., Ph.D., Head of the Department of
Rheumatology, Leiden University Medical Center, Leiden,
Netherlands,“The CHMP should be commended for the patient-focused
nature of the proposed indication language. The EU rheumatology
community benefits when treatment indications clearly define
appropriate patients based on the clinical evidence and data
provided to support the indication.” Drs. Emery and Huizinga are
co-authors of the AVERT (Assessing Very Early
Rheumatoid Arthritis Treatment) study, one of
the studies providing the basis for the positive opinion.1
The positive opinion was informed by data from two Phase 3
studies: In a 12 month, multinational, double-blind, randomized,
Phase 3B study of MTX-naive patients with early, rapidly
progressing RA, ORENCIA IV + MTX demonstrated significant efficacy
vs MTX alone for those with moderate to severe RA.2 The study,
AGREE (Abatacept study to Gauge Remission and
joint damage progression in MTX-naive patients with Early
Erosive RA), met its co-primary endpoints as defined by the
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 Sharp score: 0.6 vs 1.1, P=0.04).2
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.2
The second Phase 3 data is from the AVERT study, which compared
ORENCIA 125 mg subcutaneous + MTX combination therapy, ORENCIA 125
mg subcutaneous monotherapy, and MTX monotherapy in induction of
DAS28-defined remission following 12 months of treatment in 351
adult patients with moderately to highly active, early RA (mean
DAS28 CRP of 5.4; mean symptom duration less than 6.7 months) who
had not been treated with MTX or other DMARDs earlier (MTX-naive).1
Patients also had poor prognostic factors for rapidly progressive
disease (positive for anti-CCP antibodies, and/or RF+, presence of
baseline joint erosions).1 The co-primary endpoints compared the
proportion of patients with DAS28-defined remission (DAS28 CRP
<2.6) at month 12 and both months 12 and 18 for ORENCIA + MTX
versus MTX alone.1 At 12 months, significantly more patients on
ORENCIA combination therapy achieved DAS28-defined remission than
MTX alone (60.9%, ORENCIA + MTX; 45.2%, MTX alone).1 Similar
results at 12 months were seen with other measures of efficacy
including Boolean remission (37.0%, ORENCIA + MTX; 22.4%, MTX
alone), CDAI remission (42%, ORENCIA + MTX; 27.6% MTX alone), and
SDAI remission (42%, ORENCIA + MTX; 25% MTX alone).1 The CHMP’s
positive opinion is based on clinical response to ORENCIA as well
as X-Ray and MRI assessment of structural and inflammatory measures
of disease severity.
“The CHMP’s recommendation for ORENCIA is a milestone built on
Bristol-Myers Squibb’s commitment to advancing the science of
earlier identification of patients with progressive RA prior to
their suffering debilitating joint damage,” said Brian J. Gavin,
Vice President, ORENCIA Development Lead at Bristol-Myers Squibb.
“The potential to provide a biologic treatment option in the EU for
MTX-naive RA patients who have highly active and progressive
disease is clinically significant, and we look forward to the
European Commission decision."
About Rheumatoid
Arthritis
Rheumatoid arthritis (RA) is a systemic, chronic, autoimmune
disease characterized by inflammation in the lining of joints (or
synovium), causing joint damage with chronic pain, stiffness, and
swelling in the joints.3,4 RA causes decreased range of motion and
function in the joints.3,4 The condition is three times more common
in women than in men.3
U.S. 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.
ORENCIA® (abatacept) is a registered 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 that could lead to long-term
remission in patients with immune-mediated diseases. As we learn
more about the immune system in such diseases with substantial
unmet medical needs, the potential for developing novel therapies
that target specific pathways in 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
1. Emery P, Huizinga TW, et al. Evaluating Drug-free Remission
With Abatacept in Early Rheumatoid Arthritis. Ann Rheum Dis.
2015;74(1):19-26.2. 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):1870-1877.3. Rheumatoid
Arthritis. American College of Rheumatology. August 2012.4. Centers
for Disease Control and Prevention. Rheumatoid Arthritis. CDC
Website. http://www.cdc.gov/arthritis/basics/rheumatoid.htm.
Accessed May 19, 2016.
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Bristol-Myers Squibb CompanyMedia:Robert Perry,
407-492-4616rob.perry@bms.comorInvestors:Bill Szablewski,
609-252-5894william.szablewski@bms.com
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