THOUSAND
OAKS, Calif., April 26,
2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today
announced the imminent submission of a Marketing Authorization
Application (MAA) to the European Medicines Agency (EMA) for
teprotumumab, a fully human monoclonal antibody and targeted
inhibitor of the insulin-like growth factor-1 receptor
(IGF-1R), for the treatment of moderate to severe Thyroid Eye
Disease (TED) in adults. TED is a serious, progressive,
debilitating and potentially vision-threatening autoimmune disease
that can cause proptosis (eye bulging), diplopia (double vision),
eye pain, redness and swelling.1 If approved,
teprotumumab would be the first and only medicine approved for TED
in the European Union.
"We are enthusiastic to bring a much-needed medicine to the
Thyroid Eye Disease community in Europe by leveraging Amgen's strong reputation
and broad infrastructure in the region," said Jay Bradner, executive vice president of
Research and Development and chief scientific officer at Amgen.
"This disease is currently managed with steroids and invasive
surgeries, both of which carry their own set of risks. Having
access to a non-surgical option like teprotumumab that not only
treats the signs and symptoms, but also targets the underlying
cause of the disease represents a major advance for patients."
The MAA is supported by multiple well-controlled clinical
studies - a Phase 2 clinical study (NCT01868997)1,
Phase 3 confirmatory clinical study
OPTIC (NCT03298867)2, a Phase 4 study
(NCT04583735)3, and a Phase 3 clinical trial in
Japan (OPTIC-J,
jRCT2031210453) - providing statistically significant and
clinically meaningful improvements across multiple facets of TED,
including in proptosis and diplopia, among the 287 total patients
studied. Additionally, the studies assessed TED signs and symptoms
such as pain, inflammation, redness and functional vision. Clinical
improvements were seen in proptosis as early as six weeks, with
continued improvement across the 24-week treatment
period.2 Teprotumumab has a well-established safety
profile.
"People living with Thyroid Eye Disease, a painful and
potentially sight-threatening disease, have no approved treatment
options in Europe at this time,"
said Mario Salvi, MD, founder &
head of Graves Orbitopathy Center Aldo, Fondazione IRCCS Ca'
Granda, Milano. "When considering
the impact of this disease on patients, it's important to look
beyond the symptoms, like eye bulging and double vision, and
recognize that the inability to work, drive or even look or feel
like themselves has a serious negative impact on overall well-being
and mental health."
Teprotumumab is approved for TED in the U.S., Brazil and the Kingdom of Saudi Arabia under the brand name
TEPEZZA®, where it is administered to patients through
an intravenous (IV) infusion once every three weeks for a total of
eight infusions over the course of about five
months.1,2
In March 2024, Amgen submitted a
marketing authorization application to the Medicines and Healthcare
products Regulatory Agency (MHRA) in Great Britain, a New Drug Submission (NDS) to
Health Canada and an application to the Therapeutic Goods
Administration (TGA) in Australia
for teprotumumab. Teprotumumab is also under review by the Ministry
of Health, Labour and Welfare (MHLW) in Japan.
About Thyroid Eye Disease (TED)
TED is a serious,
progressive, debilitating and potentially vision-threatening
autoimmune disease.4 It often occurs in people
living with Graves' disease, but is a distinct disease that is
caused by autoantibodies activating an insulin-like growth factor-1
receptor (IGF-1R)-mediated signaling complex on cells within the
retro-orbital space.5,6 This leads to a cascade of
negative effects, which may cause long-term, irreversible damage,
including blindness.7,8 Signs and symptoms of TED
may include dry eyes and grittiness; redness, swelling and
excessive tearing; eyelid retraction; proptosis; pressure and/or
pain behind the eyes; and diplopia.
About TEPEZZA
Teprotumumab is marketed as TEPEZZA (teprotumumab-trbw) in
the United States. Teprotumumab is
not currently approved for commercial use in Europe.
INDICATION
TEPEZZA is indicated for the treatment of Thyroid Eye Disease
regardless of Thyroid Eye Disease activity or duration.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Infusion Reactions: TEPEZZA may cause infusion reactions.
Infusion reactions have been reported in approximately 4% of
patients treated with TEPEZZA. Reported infusion reactions have
usually been mild or moderate in severity. Signs and symptoms may
include transient increases in blood pressure, feeling hot,
tachycardia, dyspnea, headache, and muscular pain. Infusion
reactions may occur during an infusion or within 1.5 hours after an
infusion. In patients who experience an infusion reaction,
consideration should be given to premedicating with an
antihistamine, antipyretic, or corticosteroid and/or administering
all subsequent infusions at a slower infusion rate.
Preexisting Inflammatory Bowel Disease: TEPEZZA may cause
an exacerbation of preexisting inflammatory bowel disease (IBD).
Monitor patients with IBD for flare of disease. If IBD exacerbation
is suspected, consider discontinuation of TEPEZZA.
Hyperglycemia: Increased blood glucose or hyperglycemia
may occur in patients treated with TEPEZZA. In clinical trials, 10%
of patients (two-thirds of whom had preexisting diabetes or
impaired glucose tolerance) experienced hyperglycemia.
Hyperglycemic events should be controlled with medications for
glycemic control, if necessary. Assess patients for elevated blood
glucose and symptoms of hyperglycemia prior to infusion and
continue to monitor while on treatment with TEPEZZA. Ensure
patients with hyperglycemia or preexisting diabetes are under
appropriate glycemic control before and while receiving
TEPEZZA.
Hearing Impairment Including Hearing Loss: TEPEZZA may
cause severe hearing impairment including hearing loss, which in
some cases may be permanent. Assess patients' hearing before,
during, and after treatment with TEPEZZA and consider the
benefit-risk of treatment with patients.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥5% and greater
than placebo) are muscle spasm, nausea, alopecia, diarrhea,
fatigue, hyperglycemia, hearing impairment, dysgeusia, headache,
dry skin, weight decreased, nail disorders, and menstrual
disorders.
Please see Full Prescribing Information or visit
TEPEZZAhcp.com for more information.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative
medicines to help millions of patients in their fight against some
of the world's toughest diseases. More than 40 years ago, Amgen
helped to establish the biotechnology industry and remains on the
cutting-edge of innovation, using technology and human genetic data
to push beyond what's known today. Amgen is advancing a broad and
deep pipeline that builds on its existing portfolio of medicines to
treat cancer, heart disease, osteoporosis, inflammatory diseases
and rare diseases.
In 2024, Amgen was named one of the "World's Most Innovative
Companies" by Fast Company and one of "America's Best Large
Employers" by Forbes, among other external recognitions. Amgen
is one of the 30 companies that comprise the Dow Jones Industrial
Average®, and it is also part of the Nasdaq-100
Index®, which includes the largest and most innovative
non-financial companies listed on the Nasdaq Stock Market based on
market capitalization.
For more information, visit Amgen.com and follow Amgen on X,
LinkedIn, Instagram, TikTok, YouTube and Threads.
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(apremilast) (including anticipated Otezla sales growth and the
timing of non-GAAP EPS accretion), the Teneobio, Inc. acquisition,
the ChemoCentryx, Inc. acquisition, or the Horizon Therapeutics plc
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References
- Smith TJ, Kahaly GJ, Ezra DG, et al. Teprotumumab for
thyroid-associated ophthalmopathy. N Engl J
Med. 2017;376(18):1748-1761.
- Douglas RS, Kahaly GJ, Patel A, et al. Teprotumumab for
the treatment of active thyroid eye disease. N Engl J Med.
2020;382(4):341-352.
- Douglas RS, et al. Efficacy and Safety of Teprotumumab in
Patients With Thyroid Eye Disease of Long Duration and Low Disease
Activity. The Journal of Clinical Endocrinology &
Metabolism. 2023; 109 (1): 25-35.
- Barrio-Barrio J, et al. Graves' Ophthalmopathy: VISA
versus EUGOGO Classification, Assessment, and
Management. Journal of Ophthalmopathy.
2015;2015:249125.
- Weightman DR, et al. Autoantibodies to IGF-1 Binding Sites in
Thyroid Associated Ophthalmopathy. Autoimmunity.
1993;16(4):251–257.
- Pritchard J, et al. Immunoglobulin Activation of T Cell
Chemoattractant Expression in Fibroblasts from Patients with
Graves' Disease Is Mediated Through the Insulin-Like Growth Factor
1 Receptor Pathway. J Immunol. 2003;170:6348-6354.
- McKeag D, et al. Clinical features of dysthyroid optic
neuropathy: a European Group on Graves' Orbitopathy (EUGOGO)
survey. Br J Ophthalmol. 2007;91:455-458.
- Bartalena L, Kahaly GJ, Baldeschi L, et al. The 2021 European
Group on Graves' Orbitopathy (EUGOGO) Clinical Practice Guidelines
for the Medical Management of Graves' Orbitopathy [published online
ahead of print]. Eur J Endocrinol. 2021 Jul
1:EJE-21-0479.R1. doi: 10.1530/EJE-21-0479.
CONTACT: Amgen, Thousand
Oaks
Madison Howard, 773-636-4910
(media)
Jessica Akopyan, 805-440-5721
(media)
Justin Claeys, 805-313-9775
(investors)
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