Planning Underway for Phase 3 Development of
Tezepelumab in COPD
THOUSAND
OAKS, Calif., April 16,
2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today
provided an update regarding the results of the Phase 2a COURSE
trial for TEZSPIRE® (tezepelumab-ekko) in chronic
obstructive pulmonary disease (COPD), which were accepted for
presentation in the Clinical Trials Symposium at The American
Thoracic Society (ATS) 2024 International Conference on
Monday, May 20, from 9:15-11:15 a.m. PDT.
We are encouraged by the results of the COURSE
Phase 2a proof-of-concept trial, which investigated tezepelumab in
moderate to very severe COPD patients, across a broad range of
eosinophil levels, irrespective of inflammatory drivers, emphysema,
chronic bronchitis and smoking status. This study did not exclude
any patients based on their baseline eosinophil count (BEC) and
intentionally enrolled patients with a broad range of BECs.
Overall, tezepelumab numerically reduced the annualized rate of
moderate or severe COPD exacerbations versus placebo by 17% (90%
CI: −6, 36; p=0.1042). Of note, more reductions were observed in a
prespecified subgroup of patients with BEC ≥150 cells/μL (37% [95%
CI: 7, 57]). The trend in reduction was greater in a small number
of subjects with BEC ≥300 cells/µL.
"We are excited by these data and optimistic
about the potential tezepelumab has for patients with COPD, a
condition that continues to have a significant unmet medical need,"
said James Bradner, M.D., executive
vice president of Research and Development and chief scientific
officer at Amgen.
We look forward to presenting the full data set
at the congress and based on these findings, we are actively
planning for the Phase 3 development of tezepelumab in
COPD.
TEZSPIRE is a registered trademark of Amgen Inc.
and AstraZeneca.
TEZSPIRE®
(tezepelumab-ekko) U.S. Indication
TEZSPIRE is
indicated for the add-on maintenance treatment of adult and
pediatric patients aged 12 years and older with severe asthma.
TEZSPIRE is not indicated for the relief of acute bronchospasm
or status asthmaticus.
TEZSPIRE® (tezepelumab-ekko) Important Safety
Information
CONTRAINDICATIONS
Known hypersensitivity to tezepelumab-ekko or excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions
were observed in the clinical trials (e.g., rash and allergic
conjunctivitis) following the administration of TEZSPIRE.
Postmarketing cases of anaphylaxis have been reported. These
reactions can occur within hours of administration, but in some
instances have a delayed onset (i.e., days). In the event of a
hypersensitivity reaction, consider the benefits and risks for the
individual patient to determine whether to continue or discontinue
treatment with TEZSPIRE.
Acute Asthma Symptoms or Deteriorating
Disease
TEZSPIRE should not be used to treat acute asthma
symptoms, acute exacerbations, acute bronchospasm, or status
asthmaticus.
Abrupt Reduction of Corticosteroid Dosage
Do not
discontinue systemic or inhaled corticosteroids abruptly upon
initiation of therapy with TEZSPIRE. Reductions in corticosteroid
dose, if appropriate, should be gradual and performed under the
direct supervision of a physician. Reduction in corticosteroid dose
may be associated with systemic withdrawal symptoms and/or unmask
conditions previously suppressed by systemic corticosteroid
therapy.
Parasitic (Helminth) Infection
It is unknown if
TEZSPIRE will influence a patient's response against helminth
infections. Treat patients with pre-existing helminth infections
before initiating therapy with TEZSPIRE. If patients become
infected while receiving TEZSPIRE and do not respond to
anti-helminth treatment, discontinue TEZSPIRE until infection
resolves.
Live Attenuated Vaccines
The concomitant use of
TEZSPIRE and live attenuated vaccines has not been evaluated. The
use of live attenuated vaccines should be avoided in patients
receiving TEZSPIRE.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥3%) are
pharyngitis, arthralgia, and back pain.
USE IN SPECIFIC POPULATIONS
There are no available data on TEZSPIRE use in pregnant women to
evaluate for any drug-associated risk of major birth defects,
miscarriage, or other adverse maternal or fetal outcomes. Placental
transfer of monoclonal antibodies such
as tezepelumab-ekko is greater during the third trimester
of pregnancy; therefore, potential effects on a fetus are likely to
be greater during the third trimester of pregnancy.
Please see the full Prescribing
Information including Patient Information
and Instructions for Use.
About Amgen
Amgen is committed to unlocking the potential of biology for
patients suffering from serious illnesses by discovering,
developing, manufacturing and delivering innovative human
therapeutics. This approach begins by using tools like advanced
human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and
leverages its expertise to strive for solutions that improve health
outcomes and dramatically improve people's lives. A biotechnology
pioneer since 1980, Amgen has grown to be one
of the world's leading independent biotechnology
companies, has reached millions of patients around the world and is
developing a pipeline of medicines with breakaway
potential.
Amgen is one of the 30 companies that comprise the Dow
Jones Industrial Average and is also part of the Nasdaq-100 index.
In 2023, Amgen was named one of "America's Greatest Workplaces" by
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contains forward-looking statements that are based on the current
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10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen
is providing this information as of the date of this communication
and does not undertake any obligation to update any forward-looking
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identification of new product candidates or development of new
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CONTACT: Amgen, Thousand
Oaks
Jessica Akopyan, 805-440-5721
(media)
Justin Claeys, 805-313-9775
(investors)
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