Your browser does not support iframes.
Safety results from the open-label extension study of the original
U.S. COPAXONE® pivotal trial presented at the
2018 ECTRIMS Annual Meeting in Berlin
JERUSALEM--(BUSINESS WIRE)--Oct. 10, 2018--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced safety and tolerability results representing 25 years of data
from the open-label extension study of the original U.S. pivotal trial
of COPAXONE® (glatiramer acetate injection) for the treatment
of relapsing forms of multiple sclerosis (RMS). The extension study
initially examined the safety of COPAXONE® 20 mg/mL daily and
then also the 40 mg/mL three times weekly formulation when it became
available approximately 20 years later. Patients who participated in the
original 36-month, randomized placebo-controlled U.S. trial were
eligible to proceed to the open-label extension, in which patients
receiving COPAXONE® continued their treatment, while those
who received placebo were switched to COPAXONE®. Results show
that for study patients who continued to take COPAXONE®,
long-term treatment has an acceptable safety and tolerability profile
with low rates of serious adverse events (SAEs) and immediate
post-injection reactions (IPIRs).
“COPAXONE® is unique in being the only
treatment for RMS that has been studied in patients who were closely and
prospectively monitored for more than two decades,” said Danny McBryan,
M.D., Senior Vice President of Global Medical Affairs and
Pharmacovigilance at Teva. “The safety profile demonstrated by COPAXONE®
is reassuring, as it remains our priority to deliver a safe
and effective treatment option for patients with RMS.”
In addition to these 25-year data, the clinical effectiveness and safety
of this study were also reported at 2 and 3 years, and at 6, 8, 10, 15
and 20 years. These findings should be considered within the context of
the disease course of these patients, who are now approaching 35 years
with their illnesses, and also in conjunction with the existing evidence
regarding the safety and tolerability of COPAXONE® as
described in previous studies. Data on the long-term neurological
disease course and effectiveness of COPAXONE® will be
presented at a future meeting.
“Teva’s unwavering dedication to serve the MS community is deeply rooted
in the commitment to carry out this study,” said lead author and
board-certified neurologist Dr. Corey Ford, University of New Mexico
Health Sciences Center. “We are grateful for the contributions of the
study participants and their families that have allowed us to secure the
clinical evidence to reinforce COPAXONE® as a safe and
tolerable treatment option for those living with RMS.”
The poster, “Twenty-five years of continuous treatment of multiple
sclerosis with branded glatiramer acetate: long-term clinical results of
the US open-label extension study,” will be on display during Poster
Session 1 on Wednesday, October 10 from 5:00 p.m. to 7:00 p.m. CET.
COPAXONE® is indicated for the treatment of patients with
relapsing forms of multiple sclerosis. Please click here for U.S. Full
Prescribing Information: www.CopaxonePrescribingInformation.com.
Important Safety Information
COPAXONE® is contraindicated in patients with known
hypersensitivity to glatiramer acetate or mannitol.
Approximately 16% of patients exposed to COPAXONE® 20 mg per
mL compared to 4% of those on placebo, and approximately 2% of patients
exposed to COPAXONE® 40 mg per mL compared to none on placebo
experienced a constellation of symptoms that may occur immediately
(within seconds to minutes, with the majority of symptoms observed
within 1 hour) after injection and included at least 2 of the following:
flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea,
throat constriction, and urticaria. In general, these symptoms have
their onset several months after the initiation of treatment, although
they may occur earlier, and a given patient may experience 1 or several
episodes of these symptoms. Typically, the symptoms were transient and
self-limited and did not require treatment; however, there have been
reports of patients with similar symptoms who received emergency medical
Transient chest pain was noted in 13% of COPAXONE® 20 mg per
mL patients compared to 6% of placebo patients, and approximately 2% of
COPAXONE® 40 mg per mL patients compared to 1% on placebo.
While some episodes of chest pain occurred in the context of the
Immediate Post-Injection Reaction described above, many did not. The
temporal relationship of this chest pain to an injection was not always
known. The pain was usually transient, often unassociated with other
symptoms, and appeared to have no clinical sequelae. Some patients
experienced more than 1 such episode, and episodes usually began at
least 1 month after the initiation of treatment.
At injection sites, localized lipoatrophy and, rarely, injection site
skin necrosis may occur. Lipoatrophy may occur at various times after
treatment onset (sometimes after several months) and is thought to be
permanent. There is no known therapy for lipoatrophy.
Because COPAXONE® can modify immune response, it may
interfere with immune functions. For example, treatment with COPAXONE®
may interfere with recognition of foreign antigens in a way that would
undermine the body’s tumor surveillance and its defenses against
infection. There is no evidence that COPAXONE® does this, but
there has not been a systematic evaluation of this risk.
In controlled studies of COPAXONE® 20 mg per mL, the most
common adverse reactions with COPAXONE® vs placebo were
injection site reactions (ISRs), such as erythema (43% vs 10%);
vasodilatation (20% vs 5%); rash (19% vs 11%); dyspnea (14% vs 4%); and
chest pain (13% vs 6%).
In a controlled study of COPAXONE® 40 mg per mL, the most
common adverse reactions with COPAXONE® vs placebo were ISRs,
such as erythema (22% vs 2%).
ISRs were one of the most common adverse reactions leading to
discontinuation of COPAXONE®. ISRs, such as erythema, pain,
pruritus, mass, edema, hypersensitivity, fibrosis, and atrophy, occurred
at a higher rate with COPAXONE® than placebo.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global
leader in generic medicines, with innovative treatments in select areas,
including CNS, pain and respiratory. We deliver high-quality generic
products and medicines in nearly every therapeutic area to address unmet
patient needs. We have an established presence in generics, specialty,
OTC and API, building on more than a century-old legacy, with a fully
integrated R&D function, strong operational base and global
infrastructure and scale. We strive to act in a socially and
environmentally responsible way. Headquartered in Israel, with
production and research facilities around the globe, we employ 45,000
professionals, committed to improving the lives of millions of patients.
Learn more at www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
regarding COPAXONE®, which are based on
management’s current beliefs and expectations and are subject to
substantial risks and uncertainties, both known and unknown, that could
cause our future results, performance or achievements to differ
significantly from that expressed or implied by such forward-looking
statements. Important factors that could cause or contribute to such
differences include risks relating to:
and other factors discussed in our Annual Report on Form 20-F for the
year ended December 31, 2016 (“Annual Report”), including in the section
captioned “Risk Factors,” and in our other filings with the U.S.
Securities and Exchange Commission, which are available at www.sec.gov
Forward-looking statements speak only as of the date on which they are
made, and we assume no obligation to update or revise any
forward-looking statements or other information contained herein,
whether as a result of new information, future events or otherwise. You
are cautioned not to put undue reliance on these forward-looking
View source version on businesswire.com: https://www.businesswire.com/news/home/20181010005336/en/
Source: Teva Pharmaceutical Industries Ltd.
IR ContactsKevin C. Mannix, (215) 591-8912orRan
Meir, 972 (3) 926-7516orPR ContactsUnited
StatesDoris Saltkill, (913) 777-3343orIsraelYonatan
Beker, 972 (54) 888 5898