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|October 10, 2018 11:00 a.m.|
|Teva Presents 25-year Safety Data from Longest Continuous Trial of COPAXONE® (glatiramer acetate injection) for the Treatment of Relapsing Forms of Multiple Sclerosis|
Safety results from the open-label extension study of the original
U.S. COPAXONE® pivotal trial presented at the
2018 ECTRIMS Annual Meeting in
“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
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.
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
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 care.
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.
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